Pharma Books

Pharmaceutical Calculations [Hardcover]
Mitchell J. Stoklosa
(Author), Howard C. Ansel
(Author)
Editorial Reviews
Product Description
Massachusetts College of Pharmacy and Allied Health Sciences, Boston, Massachusetts. Tenth
edition of a major textboo for !harmacy students. Pre"ious edition #$$#. %n conformance &ith
the '.S. Pharmaco!eia, uses the metric system instead of the a!othecaries( system.
Con"ersion charts a!!ear in the a!!endix.
Product Details
Hardcover: )*# !ages
Publisher: +illiams , +ilins- #. Sub edition /0anuary
#1, #$$*2
Language: 3nglish
ISBN-!: .*4).4..#*
ISBN-": $546.*4).4..#4
Product Di#ensions: $.$ x *.4 x #.7 inches
Shipping $eight: 7 !ounds
Pharmaceutical Calculations [Hardcover]
Howard C. Ansel
(Author), Mitchell J. Stoklosa (Author)

Editorial Reviews
Product Description
The gold standard textbook in its area for sixt ears,Pharmaceutical Calculations is now in its Twelfth !dition.
!"er cha#ter has been re"ised and u#dated to reflect the basic calculations a##licable to the conte$#orar #ractice of
#har$ac.
This edition #ro"ides ex#anded co"erage of enteral and #arenteral nutrition. %ew features include &Calculations
Ca#sules&''boxed su$$aries of the t#e of calculation #resented in each cha#ter, and &A Case in (oint&''#ractical
cases with ste#'b'ste# solutions to de$onstrate each t#e of calculation.
)e"iew exercises at the end of the book are co$#letel u#dated. This edition includes answers to all #ractice and
re"iew #roble$s.
Product Details
Hardcover: 8*8 !ages
Publisher: 9i!!incott +illiams , +ilins- T&elfth edition
/:ecember )., 7..12
Language: 3nglish
ISBN-!: .54#5*7*1.
ISBN-": $546.54#5*7*1*
Product Di#ensions: #..7 x 5.# x ..4 inches
Cleanroom Technology: Fundamentals of
Design, Testing and Operation [Hardcover]
*illia$ *hte (Author)

Editorial Reviews
Review
;...extremely useful and hel!ful..."ery &ell6&ritten, highly organi<ed, easy to understand and
follo&...; /3n"ironmental =eology, 7..)2
Product Description
A cleanroom is a contamination6controlled en"ironment and is essential in the industrial
manufacture of many electronic, semiconductor, o!tical, !harmaceutical and medical !roducts.
The use of cleanrooms for the manufacture of a large range of !roducts such as
micro!rocessors, C: !layers, lasers, !harmaceuticals and medical de"ices continues to gro&
and many com!anies are using cleanrooms for the >rst time. At the same time, ne&
technology !roducts that can only be !roduced in cleanrooms are being de"elo!ed. This
com!rehensi"e o"er"ie& of the fundamentals, design, testing and o!eration of cleanroom
systems !ro"ides no"ices &ith a introduction to this state6of6the6art technology and
!rofessionals &ith an accessible reference to the current standards. ?eaders &ill beni>t from
the author(s )1 years of ex!erience in cleanroom technology ?,:, consultancy and teaching.
The text is com!lementary to the structure and content of +hyte(s o&n and many in6house
cleanroom courses in the electronics and !harmaceutical industries.
@ Com!lementary to the highly successful Cleanroom :esign, Second 3dition and the
forthcoming Cleanroom Testing and ?unning by the same author
@ Presents the fundamentals and latest standards for the design, "alidation, testing and
running of cleanroom systems
Pitched at introductory le"el and tailored to ful>l the training reAuirements of scientists and
engineers ne& to cleanroom technology See all 3ditorial ?e"ie&s
Product Details
Hardcover: )7. !ages
Publisher: +iley /Se!tember #7,
7..#2
Language: 3nglish
ISBN-!: .85#4*487*
ISBN-": $546.85#4*4877
Product Di#ensions: $.# x *.# x
..$ inches
OP !uidelines
:. H. Shah /Author2

Editorial Reviews
Product Description
%ntroducing the Second 3dition of our bestselling boo, the ne& edition is no& a com!rehensi"e and
cutting6edge guide to !re!aration and management of Standard B!erating Procedures. %t co"ers the >elds
of Production, Cuality Control, Cuality Assurance, Stores, 3ngineering, Maintenance and Houseee!ing.
Contains actual full text SBPs that can be inor!orated directly in your systems and modi>ed as reAuired. %t
includes for the >rst time, detailed and easy to understand methods of de"elo!ing SBPs that are reAuired
by the manufacturer and regulatory agencies. 3lectronic SBP management systems and their desired
structures are co"ered. Also included in the ne& edition are "arious systems of 3lectronic Batch ?ecords
and !harmaceutical 3?P systems and their management. CBDT3DTS %ntroduction Preface to the#st 3dition
:3S%=D%D= 3EE3CT%F3 SBPs %ntroduction and Pur!ose of SBPs Bene>ts of SBPs Ty!es of SBPs Contents of
a Ty!ical SBP 9e"el of :etail +riting Style SBP :e"elo!ment CreateG3dit ?e"ie& A!!ro"e Publish :istribute
Archi"e SBP Eormat Title Page Table of Contents Text Transition to 3lectronic SBPs Too Many :ocuments
B"er6com!lex :ocuments %na!!ro!riate Eormat Management Systems Ad"antages of 3lectronic SBPs
System ?eAuirements Structure of eSBP System Audit Critical Acti"ities Authenticate 'sers Hee! Trac of
+ho Has Seen +hat Falidation Su!!ort Euture of eSBP 393CT?BD%C MAD'EACT'?%D= eMAD'EACT'?%D=
'nderstanding the e in the eManufacturing 3lectronic ?ecords ?eAuirements for 3lectronic ?ecords ?is
Based A!!roach to Euture Pur!ose of eManufacturing %ntroduction to 3lectronic Batch ?ecords /3B?2
Bene>ts of 3lectronic Batch ?ecords /3B?2 Plant 3Iciencies %m!act of CC 9ab on Batch Cycle Time
Management of Manufacturing :ata 'ser ?eAuirement S!eci>cation /'?S2 Fendor Selection Cuali>cation
and Falidation of Soft&are 3"olution from Pa!er to 3B? Eeatures of c=MP Com!liant 3B? System Process
Historian for Management of Manufacturing :ata 3nter!rise ?esource Plan
%bout the %uthor
:. H. Shah graduated in !harmacy in #$*7 and in the last 8. years has been acti"ely associated &ith
manufacture of all categories of drug formulations. He is !resently Technical :irector &ith a fe& re!uted
!harmaceutical com!anies and is in"ol"ed in Auality assurance and =MP com!liance acti"ities. --This text
refers to an out of print or unavailable edition of this title.
Product Details
Publisher: Business Hori<ons- 7nd edition /Do"ember
#1, 7..*2
Language: 3nglish
ISBN-!: 4#$..54445
ISBN-": $5464#$..54445
Product Di#ensions: $.* x 5.8 x #.) inches
Pharmaceutical "#uipment $alidation:
The %ltimate &ualification !uide'oo(
[Hardcover]
(hil Cloud (Author)
Editorial Reviews
Product Description
+hile E:A regulations, c=MP, =9P, =CP, and the industry standard %SB $... reAuire that
documentation be established and follo&ed, they do not !ro"ide guidelines on ho& to !roduce
that documentation. Pharmaceutical 3Aui!ment Falidation gi"es details on ho& to demonstrate
com!liance, &hat data to use, and ho& to !roduce the a!!ro!riate documentation. This boo(s
user6friendly diagrams and other clear gra!hics illustrate ey ideas throughout each !rotocol,
oJering a bird(s6eye "ie& of &hat is coming next6and they Auicly guide you through the
eAui!ment "alidation. The author !ro"ides a thorough understanding of ho& to !re!are, test,
and com!lete eAui!ment Auali>cation !rotocols. He also ex!lains ho& to !erform Auali>cation
testing and &hether to test the eAui!ment for a &orst case scenario. Do other boo deals
exclusi"ely &ith the ey issues of eAui!ment Auali>cation and !rocess "alidation for
!harmaceutical !rocess eAui!ment6and !ro"ides instructions on ho& to achie"e it. +ith
!ragmatic a!!roach, this boo includes )4 useful !rotocol tem!lates, already com!leted, that
!ro"ide instant ans&ers to most !rotocol &riting and testing Auestions. These tem!lates co"er
s!eci>c eAui!ment ty!es, such, and !ro"ide accurate, industry acce!table eAui!ment
Auali>cation !rotocols. Ste!6by6ste!, they sho& ho& to Aualify each !iece of eAui!ment, and
they !ro"ide a chec for readers o&n !rotocols.
Product Details
Hardcover: 81* !ages
Publisher: %nforma Healthcare- # edition /August
)#, #$$42
Language: 3nglish
ISBN-!: #158$#.5$1
ISBN-": $546#158$#.5$5
HP)C : &uantitative *nalysis of
Pharmaceutical Formulations
P.:. Sethi /Author2
Editorial Reviews
Product Description
# cardio"ascular system. 7 musculoseletal disorders. ) antibiotics. 8 central ner"ous system.
1 alimentary system. * res!iratory system and antiallergics. 5 !re!arations for external use. 4
"itamins and miscellaneous.
%bout the %uthor
:r.P.:. Sethi obtained his Ph.:. from madras uni"ersity, Madras, %ndia. He has been !ursuning
his analytical career since last ). years. All the boos authored by him are on !ractical
a!!lication of diJerent analytical techniAues for analysis of multi6com!onent drug
formulations. these boos are the only ind on the subject. &hile ser"ing as chairman,
ayur"edic !harmaco!oeia of india, :r. Sethi &as instrumental in ado!ting T9C for >nger6!rint
!ro>ling of medicinal !lants for their correct identi>cation. it is often said that library of any
analytical laboratory, !harmaceutical institute and !harma industry is incom!lete &ithout
boos authored by :r. Sethi.
Product Details
Hardcover: $.. !ages
Publisher: CBS Publishers , :istributors /Eebruary
#1, 7..52
Language: 3nglish
ISBN-!: 4#7)$#)544
ISBN-": $5464#7)$#)54.
$alidation of Pharmaceutical Processes,
+rd "dition [Hardcover]
Ja$es (. Agalloco (!ditor), +rederick J. Carleton (!ditor)
Editorial Reviews
Product Description
Com!letely re"ised and u!dated to reKect the signi>cant ad"ances in !harmaceutical !roduction and
regulatory ex!ectations, this third edition of Falidation of Pharmaceutical Processes examines and
blue!rints e"ery ste! of the "alidation !rocess needed to remain com!liant and com!etiti"e. The many
cha!ters added to the !rior com!ilation examine "alidation and six sigma system design- the !re!aration
of ase!tic and non6ase!tic !harmaceutical !roducts- acti"e !harmaceutical ingredient and biotechnology
!rocesses, com!uteri<ed systems- Auali>cation and cleaning of eAui!ment- analytical methods, calibration
and certi>cation. As the industry(s leading source for "alidation of sterile !harmaceutical !rocesses for
more than #. years, this greatly ex!anded is a com!rehensi"e analysis of all of the fundamental elements
of this arena &ith !ractical solutions for e"ery !harmaceutical and bio6!harmaceutical !roduction !rocess.
Presenting theoretical no&ledge and a!!lied !ractical considerations, this title
!ro"ides an in6de!th discussion of recent ad"ances in sterili<ation
identi>es obstacles that may be encountered at any stage of the "alidation !rogram, and suggests the
ne&est and most ad"anced solutions
ex!lores distincti"e and s!eci>c !rocess ste!s, and identi>es critical !rocess control !oints to reach
acce!table results
blends the use of theoretical no&ledge &ith recent technological ad"ancements to achie"e a!!lied
!ractical solutions
Product Details
Hardcover: 5*. !ages
Publisher: %nforma Healthcare- )rd edition /Se!tember
71, 7..52
Language: 3nglish
ISBN-!: .48$)5.114
ISBN-": $546.48$)5.115
Pharmaceutical Product Development
[Hardcover]
%.,. Jain (!ditor)
Editorial Reviews
Product Description
Co"ers subjects such as oral liAuids, tablets, !arental !roducts, !acaging, and others &hich
are contributed by !harmacists associated &ith %ndian organi<ations and laboratories as &ell as
uni"ersities.
Product Details
Hardcover
Publisher: CBS Publishers , :istributors /Eebruary
#1, 7..52
ISBN-!: 4#7)$#)7#8
ISBN-": $5464#7)$#)7#*
Parenteral &uality Control: terility,
Pyrogen, Particulate, and Pat(age
,ntegrity Testing -Drugs and the
Pharmaceutical ciences. [Hardcover]
Michael ,. Akers (Author), -an .arri$ore (Author), -ana /ua00o (Author)
Editorial Reviews
Product Description
Baxter Pharmaceutical Solutions, Bloomington, %D. Text describes the recent ad"ances in the
"alidation and execution of testing schemes for !arenteral control. 3m!hasi<es testing
methodologies for the e"aluation of !acage integrity, >nished !roduct contamination, and
sterility. Pre"ious editionL c#$$).
Product Details
Hardcover: 8.4 !ages
Publisher: %nforma Healthcare- ) edition /Do"ember
7., 7..72
Language: 3nglish
ISBN-!: .4785.4415
ISBN-": $546.4785.441*
Product Di#ensions: $ x 1.$ x # inches
Pharmaceutical /ater: ystem Design,
Operation, and $alidation [Hardcover]
*illia$ 1. Collentro
(Author)
Editorial Reviews
Product Description
Erom chemical and biological !urity reAuirements, to system design and its im!act on &ater
!urity, to the reAuirements and restrictions im!osed by the regulators, this boo
com!rehensi"ely co"ers the uniAue &ater reAuirements of the !harmaceutical and
biotechnology industries. Beginning &ith a brief o"er"ie& of the theory and a!!lication of the
technology, +illiam Collentro clari>es the seemingly o"er&helming engineering as!ects as he
discusses design considerations, o!eration, maintenance, "alidation, and regulatory6related
to!ics bases u!on !ersonal ex!erience &ith more than 8.. !harmaceutical and related &ater
!uri>cation systems. His extensi"e >eld ex!erience and the numerous case studies recounted
in this boo ensure that all rele"ant as!ects of !harmaceutical &ater technology are
thoroughly ex!lained in a clear, concise style.Eeatures
Product Details
Hardcover: *$8 !ages
Publisher: %nforma Healthcare- # edition /Se!tember
)., #$$42
Language: 3nglish
ISBN-!: #158$#.757
ISBN-": $546#158$#.754
Product Di#ensions: #..# x 5.* x 7 inches
Hand'oo( of Pharmaceutical 0anufacturing
Formulations, econd "dition: -i12$olume et.
[Hardcover]
Sarfara0 ,. %ia0i (Author)
Editorial Reviews
Product Description
An authoritati"e and #ractical guide to the art and science of for$ulating drugs.
*ith thoroughl re"ised and ex#anded content, this Second Edition six'"olu$e set co$#iles "olu$es fro$ +-A %ew -rug
A##lications, #atent a##lications, and other sources of generic and #ro#rietar for$ulations to co"er the broad s#ectru$ of issues
concerning drug $anufacturing. A $ust'ha"e collection for #har$aceutical $anufacturers, educational institutions, and regulator
authorities, this set is an excellent #latfor$ for drug co$#anies to bench$ark their #roducts and for generic co$#anies to for$ulate
drugs co$ing off #atent. As the largest reference on #har$aceutical for$ulations, this handbook also #ro"ides guidelines on how to
file a%-As in the shortest #ossible ti$e, hel#ing #har$aceutical co$#anies to cut costs in the areas of #har$aceutical research and
de"elo#$ent. -i"ided con"enientl into two #arts2regulator and $anufacturing guidelines, and for$ulations2each "olu$e in the
set co"ers3
c=MP com!liance
!re6a!!ro"al ins!ections
stability and bioeAui"alence testing
!acaging commodity de"elo!ment
common diIculties in formulating drugs
changes to aD:As
Product Details
Hardcover: 7.$8 !ages
Publisher: %nforma Healthcare- 7 edition /Se!tember
7#, 7..$2
Language: 3nglish
ISBN-!: #87..4#.*)
ISBN-": $546#87..4#.*.
Product Di#ensions: #*.8 x #7.) x 4.1 inches
Hand'oo( of Pharmaceutical "1cipients
-3o4e, Hand'oo( of Pharmaceutical
"1cipients. [Hardcover]
)a$ond C. )owe (!ditor), (aul J. Sheske (!ditor), Marian !. 4uinn (!ditor)
Editorial Reviews
Product Description
;The Handboo of Pharmaceutical 3xci!ients; is internationally recognised as the authoritati"e source of
information on !harmaceutical exci!ients. ;The Handboo of Pharmaceutical 3xci!ients; is a
com!rehensi"e guide to the uses, !ro!erties and safety of !harmaceutical exci!ients and is an essential
reference for those in"ol"ed in the de"elo!ment, !roduction, control or regulation of !harmaceutical
!re!arations. The handboo collects together essential data on the !hysical !ro!erties of exci!ients as &ell
as !ro"iding information on their safe use and !otential toxicity. All monogra!hs are also thoroughly cross6
referenced and indexed to allo& their identi>cation by chemical, non6!ro!rietary or trade names.
%bout the %uthor
?aymond ?o&e and Paul Shesey are both editors of the !re"ious edition. ?o&e in !articular is &idely
recognised internationally as an ex!ert on !harmaceutical exci!ients
Product Details
Hardcover: 444 !ages
Publisher: Pharmaceutical Press- * edition /0uly
)#, 7..$2
Language: 3nglish
ISBN-!: .41)*$5$77
ISBN-": $546.41)*$5$7)
Product Di#ensions: ## x 4.4 x #.1 inches
0icro'ial Contamination Control in
Parenteral 0anufacturing -Drugs and
the Pharmaceutical ciences. [Hardcover]
He"in +illiams /Author2
Editorial Reviews
Review
M&ill be &elcomed by all in"ol"ed in !arenteral manufacturingM.the "alue of this boo is much more than
as a guide to contamination control- it is the setting of each cha!ter &ithin a &ider and engaging context
that maes this !ublication uniAue.63uro!ean 0ournal of Parenteral and Pharmaceutical Sciences
be &elcomed by all in"ol"ed in !arenteral manufacturingM.the "alue of this boo is much more than as a
guide to contamination control- it is the setting of each cha!ter &ithin a &ider and engaging context that
maes this !ublication uniAue.63uro!ean 0ournal of Parenteral and Pharmaceutical Sciences
Product Description
This reference sur"eys emerging trends, conce!ts, and !rocedures used in the characteri<ation and control
of contaminants- the sterile !roduction of traditional drugs and biologics- the design, construction, and
"alidation of ne& !arenteral facilities- and the monitoring of clean en"ironments6"i"idly illustrating the
routes by &hich !roducts, !rocesses, and manufacturing settings become contaminated through contact
&ith the air, &ater, ra& materials, and the actions of !ersonnel, as &ell as the current methods necessary
to successfully !reclude contamination.
Product Details
Hardcover: 5*. !ages
Publisher: %nforma Healthcare- # edition /May 7., 7..82
Language: 3nglish
ISBN-!: .47851)7.4
ISBN-": $546.47851)7.5
Product Di#ensions: $ x *.7 x #.* inches
&uantitative %nal'sis o( Drugs in
Phar#aceutical )or#ulations
*Hardcover+
P.:. Sethi /Author2
Editorial Reviews
Product Description
# introduction. 7 general reAuirements, Auality assurance and accreditation of
calibrationGtesting laboratories. ) good laboratory !ractices. 8 analytical
!rocedures and analyst "alidation. 1 !ro>le of a Auality control laboratory for
!harmaceutical units. * analgesices and anti!yretics. 5 alimentary drugs. 4
antibiotics. $ anti6inKammatory drugs. #. bronchos!asm relaxants/anti6
asthma2. ## cardio"ascular drugs. #7 ex!ectorants and cough su!!ressants.
#) eye, ear, nasal, !re!arations. #8 eratolytics and cleansers. #1
rubefacients. #* sedati"es and tranAuillisers. #5 to!ical antifungal and anti6
infecti"e !re!arations. #4 "itamins, minerals and digesti"e en<yme
!re!aration.
%bout the %uthor
:r.P.:. Sethi obtained his Ph.:. from madras uni"ersity, Madras, %ndia. He has
been !ursuning his analytical career since last ). years. All the boos
authored by him are on !ractical a!!lication of diJerent analytical techniAues
for analysis of multi6com!onent drug formulations. these boos are the only
ind on the subject. &hile ser"ing as chairman, ayur"edic !harmaco!oeia of
india, :r. Sethi &as instrumental in ado!ting T9C for >nger6!rint !ro>ling of
medicinal !lants for their correct identi>cation. it is often said that library of
any analytical laboratory, !harmaceutical institute and !harma industry is
incom!lete &ithout boos authored by :r. Sethi.
Product Details
Hardcover: *$7 !ages
Publisher: CBS Publishers , :istributors- )rd edition /0anuary #, 7..42
Language: 3nglish
ISBN-!: 4#7)$.1*.7
ISBN-": $5464#7)$.1*..
Product Di#ensions: $.* x 5.8 x #.5 inches
!ood 0anufacturing Practices for
Pharmaceuticals: * Plan for Total
&uality Control from 0anufacturer
-Drugs and the Pharmaceutical ciences.
[Hardcover]
Sidney +illig /3ditor2
Editorial Reviews
Review
;...an in"aluable resource.; 66 Unlisted Drugs
;% am !leased to add this edition to my booshelfN; 66 European Journal of Pharmaceutics and Biopharmaceutics
;Man in"aluable textM.hel!OsP any indi"idual or student learn the a!!lication of the C=MPs.; 66 Pharmaceutical
Research
;Mexcellent in !resentation and languageM.a "alue to anyone interested in drug manufacture.; 66 merican
Journal of Pharmaceutical Education
Product Description
Tem!le 'ni"., Philadel!hia, PA. 3xamines 'nited States la& and go"ernmental !olicy aJecting domestic and
multinational !harmaceutical manufacturing. ?ecommends !ragmatic &ays to inter!ret and com!ly &ith E:A
Current =ood Manufacturing Practice regulation and related criteria. Pre"ious editionL c#$$5.
Product Details
Hardcover: 5)7 !ages
Publisher: %nforma Healthcare- 1th edition /Do"ember
#1, 7...2
Language: 3nglish
ISBN-!: .4785.8714
ISBN-": $546.4785.8718
Product Di#ensions: $.# x *.) x #.* inches
&uality 3ules in Pac(aging [Paper'ac(]
0ohn Shar! /Author2
Editorial Reviews
Product Description
This ne&ly6re"ised and s!eci>cally American edition of the best6selling original is the !erfect
introduction to drug !acaging =ood Manufacturing Practice /=MP2. %t is the ideal training resource
for &orers recently hired into the !harmaceutical, chemical, biotechnology, and bul
!harmaceutical industries. The central tool for many cor!orations( introductory training, retraining,
and reinforcement !rograms, it co"ers all the drug !acaging =MP conce!ts reAuired by the 'S
E:A, the British MCA, and the 3uro!ean =MPs. %n a sim!le, no6nonsense manner, the author
ex!laining the rationale of =MP and the ey role !layed by &orers in the !roduction and
!acaging of !ure, safe, and Auality !roducts. --This text refers to an alternate Paperbac! edition.
Product Details
Paperbac,
Publisher: %nter!harm Pr- %ntl edition /0une
#$$72
ISBN-!: $$$8.#8.57
ISBN-": $546$$$8.#8.5#
Product Di#ensions: 4.4 x 1.4 x ..1
inches
Shipping $eight: #.* ounces
Pharmaceutical 0aster $alidation
Plan: The %ltimate !uide to FD*,
!0P, and !)P Compliance [Hardcover]
Syed %mtia< Haider
/Author2
Editorial Reviews
Product Description
The Master Falidation Plan !ro"ides a roadma! to management for on6time start6u! of facility o!erations,
and "alidation of existing facilities, in com!liance &ith =MP reAuirements. The lac of a com!rehensi"e
Master Falidation Plan and &ell6documented "alidation !rocedures is the main reason that ne& drug,
medical de"ice, medical eAui!ment, and related !roduct a!!lications are rejected by the E:A. %n fact, only
about 7Q of the a!!lications submitted by foreign !harmaceutical com!anies are a!!ro"ed each year. This
thorough guide !ro"ides the needed solutions and guidance for both foreign and '.S. com!anies to
achie"e E:A com!liance and authori<ation to maret their !roducts in the 'nited States. Pharmaceutical
Master Falidation PlanL The 'ltimate =uide to E:A, =MP, and =9P Com!liance &ill allo& you to more easily
achie"e satisfactory ins!ections, ne& medical !roduct a!!ro"al, minimi<e non6conformance, reduce re&or
and rejected lots, and a"oid recall lots by de"elo!ing and managing a Master Falidation Plan. The
accom!anying C: allo&s users to in!ut the tem!late !lan into their com!uters and tailor it to incor!orate
additional regulatory reAuirements s!eci>c to indi"idual com!anies &orld&ide and !rint the reAuired
documents. Together, the boo and C: contain e"erything reAuired to de"elo! and execute a successful
Master Falidation Plan based on E:A guidelines for the !harmaceutical industry, and allo&s the tem!lates
to be extended to diagnostic !roducts, medical de"ice, medical eAui!ment, and biotech industry !roducts.
Product Details
Publisher: %nforma Healthcare /:ecember 75, 7..#2
Language: 3nglish
ISBN-!: #15888)).1
ISBN-": $546#15888)).#
Product Di#ensions: 4.$ x *.# x ..5 inches
Hand'oo( of Pharmaceutical
!ranulation Technology -Drugs and the
:ili! M. Parih /3ditor2
Editorial Reviews
Review
Mcom!rehensi"eM.
M "ery useful for !harmaceutical !rofessionals.
6%AS% Polytechnic Maga<ine /for !re"ious edition2 --This text refers to an alternate "ardcover edition.
Product Description
This !ractical guide integrates the basic !rinci!les and current industrial !ractices of !harmaceutical
granulation !roduction-discussing state6of6the6art technologies and demonstrating cost6eJecti"e
a!!roaches to manufacturing solid6dosage forms &ith content uniformity and consistent !hysical
!ro!erties &hile com!lying &ith regulatory reAuirements.
Product Details
Publisher: %nforma Healthcare /0une #5, #$$52
Language: 3nglish
ISBN-!: .4785$447#
ISBN-": $546.4785$447*
Product Di#ensions: $.# x *.# x #.) inches
Shipping $eight: #.5 !ounds
Pharmaceutical Process $alidation: *n

,nternational -Drugs and the
?obert A. Dash /3ditor2, Alfred H. +achter /3ditor2
Editorial Reviews
Product Description
Ste"ens %nstitute of Technology, Hoboen, D0. :etails strategies to establish a!!ro!riate
"alidation !rotocols and conduct !rocess "alidation assignments, monitor and test s!eci>c
manufacturing !rocesses for com!liance &ith design limits, and more.
Product Details
Hardcover: 55* !ages
Publisher: %nforma Healthcare- ) edition /March
75, 7..)2
Language: 3nglish
ISBN-!: .4785.4)41
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&uality Control of Her'al Drugs [Hardcover]
Pulo H Muherjee /Author2
Editorial Reviews
Product Description
An exhausti"e and com!rehensi"e boo a"ailable on the subject. %t includes information onL
Safet and Toxicit in Herbal -rugs
!thnobotan in -rug !"aluation
Macro'Mor#hogra#hical Studies
-e"elo#$ent of Standardi0ation (ara$eters
(htoconstituents and Their Analsis
!xtraction of Herbal -rugs
T.C ' -etailed (rocedures and /uidelines
H(T.C ' -ensito$etr
(har$acological Screening of Herbal -rugs
/ood Agricultural and Har"esting (ractices
4ualit Assurance and Stabilit Testing of Herbal -rugs
Analtical (rofiles of Selected Medicinal (lants
(lus Annexed 5nfor$ation
Additional )eferences
5nternet )esources for further infor$ation
5nternational Associations67rgani0ations
8ou %eed This 9ook 5f 8ou Are 3
/rower of $edicinal herbs
*holesaler6-istributor
Manufacturer of Herb !xtracts
Manufacturer of Herbal +or$ulations
)esearcher
Acade$ician
)egulator Affairs S#ecialist
%bout the %uthor
:r. Pulo H Muherjee obtained his Ph.: in herbal medicine and is a reno&ned !ersonalty in the >rel of
herbal medicine. He has to his credit o"er #.. research !a!ers in "arious international journals and one
!atent. He is !resently :irector, School of Datural Product Studies, 0ada"!ur 'ni"ersity, Holata, %ndia
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7..72
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The Pharmaceutical Code1: Principles
and Practice of Pharmaceutics -5ritish
Pharmaceutical Code1. [Hardcover]
+alter 9und /3ditor2
Editorial Reviews
Product Description
This edition of the codex has been re"ised and incor!orates u!dated material as &ell as ne&
subject areas. The codex !ro"ides a reference source on all as!ects of !harmaceutical science
and technology that are rele"ant to the de"elo!ment and !ro"ision of medicines.
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Pharmaceutical Dosage Forms [Hardcover]
Herbert 9ieberman /3ditor2, Martin ?ieger /3ditor2, =ilbert S. Baner
/3ditor2
Editorial Reviews
Review
;Mhighly recommended.; 66 Pharmaceutical Development and Technolog#
;Mhighly "aluable... ;MmanageOsP to nicely combine a historical account &ith the mandatory
inter!retation of go"ernmental regulations. 66 Pharmaceutical Development and Technolog#
Product Description
Stressing the theory in"ol"ed in formulating sus!ensions, emulsions, and colloidal drug
!roducts, this Second 3dition of a &ell6recei"ed reference test highlights ty!ical formulations,
the a"oidance of formulation !itfalls, and com!liance &ith established regulatory !rinci!les.
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#*, #$$*2
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5ritish Her'al Pharmacopoeia [Hardcover]
British Herbal Medicine Association /Author2

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Pharmaceutical Dosage Forms: Ta'lets,
Third "dition -Three2$olume et.
[Hardcover]
9arry 9. Augsburger /3ditor2, Ste!hen +. Hoag /3ditor2
Product Description
The ultimate goal of drug !roduct de"elo!ment is to design a system that maximi<es the
thera!eutic !otential of the drug substance and facilitates its access to !atients.
Pharmaceutical Dosage Forms: Tablets, Third Edition is a com!rehensi"e resource of the
design, formulation, manufacture, and e"aluation of the tablet dosage form, and &ith o"er 5..
illustrations it guides !harmaceutical scientists and engineers through diIcult and technical
!rocedures in a sim!le easy6to6follo& format.
%ew to the third edition3
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), 7..42
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Pharmaceutical Dosage Forms Ta'lets 2
6nd "dition [Hardcover]
HA9ibrman /Author2
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Hardcover
Publisher: %nforma Hralthcarr,#$$. /#$$.2
%SIN: B..)RBPT7+
Pharmaceutical Dosage Forms:
Parenteral 0edications, $olume ,
-Parenteral 0edications, 7. [Hardcover]
Henneth 3. A"is /3ditor2,
Editorial Reviews
Review
This boo forms !art of a )6"olume set &hich is a standard reference &or for the formulation and
manufacture of !arenteral dosage forms. . . . . .co"erage. . .is "ery com!rehensi"e. . . . . .The entire series
is !robably the best source for information of the dis!arate multidisci!linary area &e call !harmaceutics,
and is essential reading for all in this area.
6660ournal of Pharmacy and Pharmacology
. . .3"ery cha!ter has been re"ised and u!dated to ee! !ace &ith ad"ances in science and technology.
The editors did a good job of systematically organi<ing the contents of the text into three "olumes. . .The
>rst "olume deals &ith !erformultion, formulation, and !roduct de"elo!ment. . . .&ell illustrated &ith
!hotogra!hs, diagrams, and Ko& charts. . .The contributing authors. . .ha"e im!ressi"e credentials and
their "ie&s and ex!eriences enhance the "alue of the boo. . .strongly recommendOedP. . .for both students
and !rofessionals, both in academics and in industry.
666BioPharm
Product Description
'ni"ersity of Tennessee, Mem!his. ?e"ised and ex!anded edition of an in6de!th text on !arenteral
medications, for graduate and undergraduate students, and industrial or hos!ital !harmacists. To be
com!leted in three "olumes. Content for all "olumes gi"en in Folume #. :D9ML %nfusions.
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The Theory and Practice of ,ndustrial

Pharmacy [Hardcover]
9eon 9achman
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"uropean Customs ,nventory of
Chemical u'stances: * !uide to the
Classification of Chemicals in the
Com'ined 8omenclature: $ol 7 [,mport]
[Paper'ac(]
3uro!ean Communities /Author2
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OP !uidelines [Hardcover]
:. H. Shah /Author2
Editorial Reviews
Product Description
%ntroducing the Second 3dition of our bestselling boo, the ne& edition is no& a com!rehensi"e and
cutting6edge guide to !re!aration and management of Standard B!erating Procedures. %t co"ers the >elds
of Production, Cuality Control, Cuality Assurance, Stores, 3ngineering, Maintenance and Houseee!ing.
Contains actual full text SBPs that can be inor!orated directly in your systems and modi>ed as reAuired. %t
includes for the >rst time, detailed and easy to understand methods of de"elo!ing SBPs that are reAuired
by the manufacturer and regulatory agencies. 3lectronic SBP management systems and their desired
structures are co"ered. Also included in the ne& edition are "arious systems of 3lectronic Batch ?ecords
and !harmaceutical 3?P systems and their management. CBDT3DTS %ntroduction Preface to the#st 3dition
:3S%=D%D= 3EE3CT%F3 SBPs %ntroduction and Pur!ose of SBPs Bene>ts of SBPs Ty!es of SBPs Contents of
a Ty!ical SBP 9e"el of :etail +riting Style SBP :e"elo!ment CreateG3dit ?e"ie& A!!ro"e Publish :istribute
Archi"e SBP Eormat Title Page Table of Contents Text Transition to 3lectronic SBPs Too Many :ocuments
B"er6com!lex :ocuments %na!!ro!riate Eormat Management Systems Ad"antages of 3lectronic SBPs
System ?eAuirements Structure of eSBP System Audit Critical Acti"ities Authenticate 'sers Hee! Trac of
+ho Has Seen +hat Falidation Su!!ort Euture of eSBP 393CT?BD%C MAD'EACT'?%D= eMAD'EACT'?%D=
'nderstanding the e in the eManufacturing 3lectronic ?ecords ?eAuirements for 3lectronic ?ecords ?is
Based A!!roach to Euture Pur!ose of eManufacturing %ntroduction to 3lectronic Batch ?ecords /3B?2
Bene>ts of 3lectronic Batch ?ecords /3B?2 Plant 3Iciencies %m!act of CC 9ab on Batch Cycle Time
Management of Manufacturing :ata 'ser ?eAuirement S!eci>cation /'?S2 Fendor Selection Cuali>cation
and Falidation of Soft&are 3"olution from Pa!er to 3B? Eeatures of c=MP Com!liant 3B? System Process
Historian for Management of Manufacturing :ata 3nter!rise ?esource Plan
%bout the %uthor
!harmaceutical com!anies and is in"ol"ed in Auality assurance and =MP com!liance acti"ities. --This text
refers to an out of print or unavailable edition of this title.
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#1, 7..*2
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ISBN-!: 4#$..54445
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Pharmaceutical Facility 0anagement
[Hardcover]
0 P S Hohli /Author2
Editorial Reviews
Product Description
Business entities ha"e come to reali<e that maintaining a &ell6managed and highly eIcient
facility is critical to success. De& technologies, security issues and health concerns also ha"e
had a major im!act on the im!ortance of, and need for, facility !rofessionals in organi<ations.
Plant managers must therefore be eAui!!ed &ith a tremendous amount of no&ledge and the
ability to co!e &ith and sol"e a multitude of com!lex !roblems and challenges. The current
climate of increased ins!ections and scrutiny from the regulatory authorities on
manufacturing, combined &ith the uncertainty of the eAuity marets, has ele"ated =MP
com!liance to a long6term business strategy. This uniAue boo co"ers the often o"erlooed
>eld of !harmaceutical facility management. %n a running !harmaceutical !lant, the !lant
manager often has to manage a &ide range of acti"ities including !roduction, machine
maintenance, building maintenance, training of !ersonnel, "alidation !rograms, en"ironmental
monitoring and last but not the least S managing regulatory ins!ections. This &ide s!ectrum of
acti"ities entails the in"ol"ement of !eo!le from !roduction, Auality control, engineering,
Auality assurance, houseee!ing etc. thus demanding a lot of time and eJorts from the !lant
manager to eJecti"ely synchroni<e all these acti"ities. This boo &ill hel! in designing and
im!lementing all these reAuired acti"ities and hel! in streamlining the total functioning of a
!harmaceutical facility. This is a must6ha"e boo that all !lant mangers and others in"ol"ed
&ith a !harmaceutical manufacturing facility should ha"e on their tables for ready reference.
%bout the %uthor
0. P. S. Hohli is a !harmacy graduate from 'ni"ersity of :elhi follo&ed by :i!loma in
Management of Technology Transfer, Patents and %nformation Systems. He has &ide ranging
ex!erience in the !harmaceutical industry, ha"ing &ored in a !harmaceutical engineering
com!any follo&ed by &oring in a !harmaceutical manufacturing facility as Manager6Projects
and 3x!orts. He later set u! his o&n !harmaceutical engineering com!any !ro"iding technical
audit ser"ices and engineering consultancy to !harmaceutical com!anies for all dosage forms
lie Tablets, Ca!sules, :ry Syru!s, 9iAuid Brals, Bintments and %njectables.
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7..12
ISBN-!: 4#$..544*.
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Principles 9 Practice Contamination
Control 9 Cleanrooms [Hardcover]
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Publisher: Pharma Boo Syndicate /0anuary #, 7..)2
ISBN-!: 4#4488$.8.
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&* 0anual [Hardcover]
:. H. Shah /Author2
Editorial Reviews
Product Description
This is a com!rehensi"e and detailed guide to management of Cuality Assurance in !harmaceutical
!roduction facilities.
5t includes
+acilit -esign
!:ui#$ent
(roduction Controls
9ulk (har$aceutical Che$icals
.aborator Controls
(ersonnel
1alidation
-ocu$entation
Audits
A $anufacturer $ust, in designing, $aking and $arketing a $edicine, satisf the regulator authorities and hi$self that his #roducts
are of ade:uate :ualit, safet and efficac. A##lication of the #rinci#les of :ualit assurance and of good $anufacturing sur"eillance,
all contribute to the assurance of :ualit. The #ur#ose of this book therefore is to #ro"ide an instant knowledge'base of such sste$s
and #rocedures which will hel# a #har$aceutical $anufacturer to co$#l with $ost countries legislation;s with regard to :ualit
assurance and c/M( re:uire$ents.
%bout the %uthor
!harmaceutical com!anies and is in"ol"ed in Auality assurance and =MP com!liance acti"ities.
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7..72
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3ules and !uidance for Pharmaceutical
0anufacturers and Distri'utors 6::;:
a(a the Orange !uide [Paper'ac(]
MH?A /3ditor2
Editorial Reviews
Product Description
Eamiliarly no&n as the ;Brange =uide,; this title combines the major !harmaceutical ?egulations,
:irecti"es and guidance, &hich &holesalers and the !harmaceutical industry use as their main source
&hen manufacturing and distributing medicinal !roducts in the 3'.
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74, 7..52
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!ood 0anufacturing Practices and
,nspection -&uality *ssurance of
Pharmaceuticals. [Paper'ac(]
+orld Health Brgani<ation /Author2
Editorial Reviews
Product Description
Cuality assurance of !harmaceutical !roducts is a continuing concern of +HB. :es!ite eJorts made
around the &orld to ensure a su!!ly of Auality and eJecti"e medicines, substandard, s!urious and
counterfeit !roducts still com!romise health care deli"ery in many countries. To res!ond to the global need
for adeAuate Auality assurance of !harmaceuticals, +HB(s 3x!ert Committee on S!eci>cations for
Pharmaceutical Pre!arations has o"er the years made numerous recommendations to establish standards
and guidelines and to !romote the eJecti"e functioning of national regulatory and control systems and the
im!lementation of internationally agreed standards by trained !ersonnel. Many of the rele"ant documents
endorsed by the Committee are re!roduced in this "olume, !ro"iding guidance co"ering all as!ects of
good manufacturing !ractices /=MP2. %m!ortant texts on ins!ection are also included. Most of the material
has been !ublished se!arately in the 3x!ert Committee(s re!orts. This com!endium brings it together to
mae it more accessible and of greater !ractical "alue to those &oring in faculties of !harmacy, in
medicines regulation and control, and in the !harmaceutical industry.
%bout the %uthor
'DA%:S
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/0une *, 7..52
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Drug Formulations 0anual
-.(.S. ,ohli and -.H. Shah, !astern (ublishers, <==>, Third !dition, >?@ #, figs, tables
Erom the !refaceL ;The third edition enlists 87. drug formulations and manufacturing !rocesses. Some of
the )$ ne& formulations no& included areL Acarbose tablets, =lime!iride and !ioglita<one hydrochloride
tablets, Metformin and gli!i<ide tablets, Ator"astatin tablets, Clo!idogrel tablets, Dabumetrone tablets,
Eexofenadine tablets, ?iser!ridone tablets, =atiKoxacin tablets, =aba!entin ca!sules, Dicerbium tablets,
?am!ril ca!sules and 75 more formulations.;
&uality *ssurance in pices *nd pice
Products < 0odern of *nalysis
Product Details
-n,nown Binding
Publisher: Allied Publishers P"t. 9td. /#$$$2
ISBN-!: 4#5.7)4$*T
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Clar(e=s *nalysis of Drugs and Poisons,
Third "dition [Hardcover]
Anthony C. MoJat /3ditor2
Editorial Reviews
Product Description
'ni". of 9ondon, 'H. ?eference guide !ro"ides analytical data for drugs and !oisons. Eirst "olume details
analytical toxicology techniAues and the second "olume deals &ith the a!!lications of toxicology
techniAues in a &ide "ariety of settings. Eeatures more than #,5). monogra!hs. Pre"ious editionL c#$4*,
&as titled Clare(s %solation and %denti>cation of :rugs.
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Publisher: Pharmaceutical Press- ) edition /Eebruary
7$, 7..82
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Facility $alidation: Theory, Practice, and
Tools
=raham C. +rigley
/Author2
Editorial Reviews
Product Description
Eocusing on "alidation issues s!eci>c to the start6u! of a ne& or u!graded manufacturing facility, this boo
!ro"ide de>nitions of the !olicies, guidelines, and regulations relating to =ood Manufacturing Practices
/=MPs2 in !harmaceutical industries &orld&ide. The author discusses the "alidation conce!ts, de>nitions,
and terminology associated &ith =MPs and details the !hiloso!hy and ey !rinci!les of "alidation. He
demonstrates ho& to set u! an infrastructure for im!lementing a "alidation !rogram. %ncluded in the boo
are !ractical exam!les of "alidation documents and SBPs, a com!rehensi"e glossary of "alidation
terminology, and best !ractices for e"aluating "alidation !rograms.
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Hardcover: #*. !ages
Publisher: %nforma Healthcare- # edition /March
7$, 7..82
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ISBN-!: .48$)7)8.#
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Hand'oo( of ta'ility Testing in
Pharmaceutical Development:
3egulations, 0ethodologies, and 5est
Practices [Hardcover]
Him Huynh6Ba /3ditor2
Editorial Reviews
Product Description
A C7M()!H!%S51! A%- ()ACT5CA. /A5-! T7 STA95.5T8 T!ST5%/ 5% (HA)MAC!AT5CA. -!1!.7(M!%T
Stabilit testing is re:uired to de$onstrate that a #har$aceutical #roduct $eets its acce#tance criteria throughout its shelf life and to
gain regulator a##ro"al for co$$erciali0ation. Assessing drug #roduct stabilit and safet can be :uite co$#licated, and stabilit
#rofile can i$#act $an functional areas, including analtical testing, for$ulation de"elo#$ent, toxicolog, :ualit, and regulator
affairs.
Handbook of Stabilit Testing in (har$aceutical -e"elo#$ent3 )egulations, Methodologies, and 9est (ractices is the first "olu$e to
co"er all as#ects of stabilit testing in #har$aceutical de"elo#$ent. 5t #resents a scientific understanding of regulations and balances
$ethodologies and best #ractices. Co$#rising BC cha#ters, it #ro"ides a wealth of resources for #har$aceutical co$#anies,
educational institutions, and $anufacturing laboratories to use as either a su##le$entar text for stabilit training courses or as a
reference book for #har$aceutical #ractitioners.
To#ics co"ered include3
9atest regulations for stability testing, including c=MP reAuirements, %CH guidelines, and global
guidances from +HB, AS3AD, 3M?B, and other regions.
Post6a!!ro"al considerations and regulatory >ling strategies to su!!ort a global su!!ly chain.
Methodologies, including de"elo!ment of a stability6indicating method, method "alidation, and
transfer. This boo also discusses !hysical stability, non6chromatogra!hic methodologies, and
s!ectrosco!ic a!!lications.
Setting s!eci>cations, monitoring im!urities, and establishing shelf6life of !harmaceutical
!roducts.
:ata management, including stability re!orts, CMC, and discussion of out6of6s!eci>cation /BBS2
and out6of6trend /BBT2.
'SP6DE testing in su!!ort of stability.
Current industry best !ractices on stability o!eration, "alidation, and calibration of stability
chambers including considerations for !hoto6stability testing.
:iscussion of matrixing and braceting to su!!ort reduced stability testing.
B"er"ie& of stability !rograms for biologics and drug6in6de"ices !harmaceutical !roducts.
This collecti"e work was written b a grou# of #ro$inent international ex#erts, who ha"e been directl res#onsible for instituting
industr best #ractices and establishing the current stabilit guidelines.
%bout the %uthor
>im Huynh25a is Technical -irector of (har$altik. She has o"er <= ears of ex#eriences in "arious analtical areas of
#har$aceutical de"elo#$ent, es#eciall in Stabilit Sciences. She has in"ol"ed with se"eral #roDects har$oni0ing or o#ti$i0ing
analtical best #ractices in se"eral co$#anies, including those are under Consent -ecree. Ms. Hunh'9a has authored nu$erous
technical #ublications and book cha#ters. She is a fre:uent in"ited s#eaker at national and international conferences. She has
conducted se"eral training courses on stabilit co$#liance and :ualit issues for A$erican Che$ical Societ, A$erican Association of
(har$aceutical Scientists, (har$aceutical Training 5nstitute, !astern Analtical S$#osiu$ since <==B. She is the founder of AA(S
Stabilit +ocus /rou# and acti"el in"ol"ed with (har$aceutical Stabilit -iscussion /rou#. She is an acti"e $e$ber of ACS, AA(S,
(S-/, AS4, (7MA and ser"es in the /o"erning 9oard of !astern Analtical S$#osiu$ (!AS).
5n $ #rofessional career as a #har$aceutical scientist, 5 ha"e been in"ol"ed with se"eral as#ects of the drug de"elo#$ent #rocess
fro$ #re'5%- to co$$ercial and, so$ehow, 5 usuall found $self co$ing back to a stabilit related issue. Stabilit area see$s to
draw $ ut$ost interest because in $ da'to'da work, $ o##ortunities in"ol"ed $ore than one #roduct, and none of the issues
was the sa$e. !ach situation #osed challenges that usuall re:uired an exercise of Dudg$ent, an understanding of regulations,
knowledge of science, a gras# of co$#liance, and an a##reciation of co$$on #ractices.
Since earl <===, 5 ha"e also been in"ol"ed with se"eral training o##ortunities and 5 struggled to find good, concise, #ractical
resources, one of which 5 can Dust hand to a new scientist who wishes to gain $ore understanding of stabilit sciences. 5n addition, 5
encountered the sa$e :uestions #osted o"er and o"er on different stabilit best #ractices discussion foru$s.
As a book lo"er, 5 also ha"e a good collection of technical books. Anfortunatel, $ost of the stabilit related books are outdated. 5n
addition, $an of these $aterials are theoretical and do not contain $uch #ractical infor$ation. 5 understand that the #har$aceutical
industr during this #eriod is :uite "olatile, and guidelines are changing ra#idl while regulator agencies are working closel with
the #har$aceutical industr to acco$$odate these changesE howe"er, the funda$ental infor$ation continues to re$ain :uite the sa$e
as current /ood Manufacturing (ractices (c/M() continues to be the standard industr #ractice. Therefore, 5 ho#e to asse$ble a
#ractical handbook to fill this "oid.
Product Details
Hardcover: )4$ !ages
Publisher: S!ringer- # edition /Do"ember
7#, 7..42
Language: 3nglish
ISBN-!: .)4541*7*$
ISBN-": $546.)4541*7*#
Product Di#ensions: $.) x *.7 x #.# inches
$alidation tandard Operating
Procedures: * tep 'y tep !uide for
*chieving Compliance in the
Pharmaceutical, 0edical [Hardcover]
Syed %mtia< Haider
/Author2
Editorial Reviews
Product Description
Bne of the most common reasons so many ne& drug, medical de"ice, or eAui!ment a!!lications are
rejected each year by the E:A is the failure to !ro!erly de"elo! and document !lans and !rocedures. This
is reAuired of both '.S. and foreign com!anies &ishing to maret their !roducts in the 'nited States. The
lac of &ell de>ned "alidation standard o!erating !rocedures may result in ad"erse E:A >ndings, recalls,
and hea"y >nancial losses. Hey E:A guidelines on good manufacturing !ractice /=MP2, good laboratory
!ractice /=9P2, and "alidation do not describe exactly ho& to de"elo! a master "alidation !lan, ho& to
achie"e com!liance, or the standard o!erating !rocedures and documentation reAuired. This text !ro"ides
the reAuired "alidation standard o!erating !rocedures and documentation necessary for achie"ing
com!liance in the !harmaceutical industry. The text and C: are designed to minimi<e &orload and
o!timi<e time, money, and resources. A com!rehensi"e &hen6and6ho&6to6do6it guide, Falidation Standard
B!erating Procedures !ro"ides the needed administrati"e solutions and guidance for achie"ing com!liance
&ith E:A reAuirements, and for obtaining authori<ation to maret !roducts in the 'nited States. The C:6
?BM contains 58 tem!late "alidation standard o!erating !rocedures that can be tailored to meet the
regulatory com!liance reAuirements of any !harmaceutical, diagnostic, medical de"ice, medical
eAui!ment, and biotech !roduct. Uou can edit, !rint, and customi<e these !rocedures to >t your needs. The
boo and C: &or together to minimi<e the number of documents used and to ensure their accuracy. All
critical elements and reAuirements of "alidation are co"ered, so you can easily im!lement them and a"oid
the stress that usually accom!anies an E:A audit.Eeatures;Pro"ides all the information that managers
need to establish functions, acce!tance criteria, and "alidation !rocedures in com!liance &ith E:A
guidelines;%ncludes ste!6by6ste! directions for translating =MP reAuirements into action, based on your
com!any(s Master Falidation Plan and execution !rotocols ;:escribes ho& to establish test functions and
!re"ent defects in order to !roduce !roducts that are >t for use;Ser"es as an ideal com!anion to Haider(s
Pharmaceutical Master Falidation Plan
%bout the %uthor
Haider- Syed %mtia< =ulf Pharmaceuticals %ndustries, 'nited Arab 3mirates,
Product Details
Hardcover: 8$* !ages
Publisher: %nforma Healthcare- # edition /:ecember
75, 7..#2
Language: 3nglish
ISBN-!: #15888))#)
ISBN-": $546#15888))#4
Product Di#ensions: $.1 x *.) x #.) inches
5ritish Pharmacopoeia 7?@:: 6v [Hardcover]
:e!t.of Health , Social Security /Author2
Product Details
Hardcover: #77* !ages
Publisher: Stationery BIce Boos- 7nd edition /0une #, #$4.2
ISBN-!: .##)7.*445
ISBN-": $546.##)7.*44$
The Pharmacopeia of the %nited tates of *merica -The %nited
tates pharmacopeia. -7@6:.
AuthorL 'nited States Pharmaco!oeial Con"ention
FolumeL #$.1 4 ed.
SubjectL Pharmaco!oeias
PublisherL 3aston, Pa. Oetc.P
9anguageL 3nglish
Call numberL AAT6))##
:igiti<ing s!onsorL 'ni"ersity of Toronto
Boo contributorL =erstein 6 'ni"ersity of Toronto
CollectionL toronto
Description
Title "aries slightl
BF<='BGC> issued b authorit of the Anited States (har$aco#oeial Con"ention (BF<='G= under "arious earlier na$es of the
Con"ention)
So$e re"isions ha"e su##le$ents
Su##le$ents issued BGC>'CG also co"er the %ational for$ular ()SB@B.<%?)
Continued b the Anited states #har$aco#eia
*nalytical 0ethod $alidation and
,nstrument Performance $erification
[Hardcover]
T<e6Eun Chan /3ditor2,

Editorial Reviews
Review
V%t is a treasure of hel!ful hints and techniAues &hich can aid e"en ex!erienced analysts through some of
the %CH !rocedures.W /$etrohm %nformation, 8th 0uly 7..12
&*hile $ost useful for #har$aceutical laboratories, it $a also be useful in certain uni"ersit and go"ern$ent laboratories.& (E-
STREAMS, +ebruar <==>)
&Ha treasure of hel#ful hints and techni:ues that can aid e"en ex#erienced analsts through so$e of the 5CH #rocedures.& (Inside
Laboratory Management, Jul6August <==@)
&/i"en the need for generating reliable analtical data, this book #ro"ides #ractical guidance for "alidating co$$on and not'so'
co$$on analtical $ethods and for "erifing the #erfor$ance of instru$entsH& (Journal of the American Chemical Society, June G,
<==@)
IHa "er useful reference textHwar$l reco$$endedJ (Organic rocess Research ! "e#elo$ment Journal)
Product Description
Falidation describes the !rocedures used to analy<e !harmaceutical !roducts so that the data generated
&ill com!ly &ith the reAuirements of regulatory bodies of the 'S, Canada, 3uro!e and 0a!an. Calibration of
%nstruments describes the !rocess of >xing, checing or correcting the graduations of instruments so that
they com!ly &ith those regulatory bodies. This boo !ro"ides a thorough ex!lanation of both the
fundamental and !ractical as!ects of bio!harmaceutical and bioanalytical methods "alidation. %t teaches
the !ro!er !rocedures for using the tools and analysis methods in a regulated lab setting. ?eaders &ill
learn the a!!ro!riate !rocedures for calibration of laboratory instrumentation and "alidation of analytical
methods of analysis. These !rocedures must be executed !ro!erly in all regulated laboratories, including
!harmaceutical and bio!harmaceutical laboratories, clinical testing laboratories /hos!itals, medical oIces2
and in food and cosmetic testing laboratories.
See all 3ditorial ?e"ie&s
Product Details
Hardcover: )7. !ages
Publisher: +iley6%nterscience- # edition /0anuary
74, 7..82
Language: 3nglish
ISBN-!: .85#71$1)1
ISBN-": $546.85#71$1)8
Product Di#ensions: $.8 x *.8 x ..4 inches
Pharmaceutical *nalysis [Hardcover]
T. Higuchi /3ditor2
Product Details
Publisher: 0ohn +iley , Sons %nc /:ecember #$*#2
Language: 3nglish
ISBN-!: .85.)$1)8*
ISBN-": $546.85.)$1)8$
$alidation and &ualification in *nalytical
)a'oratories [Hardcover]
9ud&ig Huber
/Author2
Editorial Reviews
Review
a great single reference containing all you e"er &anted to no& about "alidating and "erifying assay or
eAui!ment !erformance.
Dood#&s Revie' - (alerie ). *g+ PhD+ $D
Product Description
This Second Edition discusses &ays to im!ro"e !harmaceutical !roduct Auality &hile achie"ing
com!liance &ith global regulatory standards. +ith com!rehensi"e ste!6by6ste! instructions, !ractical
recommendations, standard o!erating !rocedures /SBPs2, checlists, tem!lates, and gra!hics for easy
incor!oration in a laboratory. This title ser"es as a com!lete source to the subject, and ex!lains ho& to
de"elo! and im!lement a "alidation strategy for routine, non6routine, and standard analytical methods,
co"ering the entire eAui!ment, hard&are, and soft&are Auali>cation !rocess. %t also !ro"ides guidance on
Auali>cation of certi>ed standards, in6house reference materials, and !eo!le Auali>cation, as &ell as
internal and third !arty laboratory audits and ins!ections.
Product Details
Publisher: %nforma Healthcare- 7 edition /0uly
7), 7..52
Language: 3nglish
ISBN-!: .48$)47*5T
ISBN-": $546.48$)47*5)
Product Di#ensions: $ x *.# x ..4 inches
5ritish Pharmaceutical Code1 7?;+
[Hardcover]
Pharmaceutical Society of =reat Britain /Author2
Product Details
Hardcover: #.78 !ages
Publisher: The Pharmaceutical Press /0une #$5)2
Language: 3nglish
ISBN-!: .41)*$.485
ISBN-": $546.41)*$.48$
0icro'iological Contamination Control
in Pharmaceutical Clean 3ooms [Hardcover]
Digel Halls /3ditor2
Editorial Reviews
Review
MThroughout the boo one >nds concise, !ractical and hel!ful cha!ters and sections. 3"erything &ithin
the boo a"oids unnecessary descri!tions, but comes to the !oint underlined by years of ex!erienceM.
Man excellent !ractical referenceM.An enjoyment to read and learn.
63uro!ean 0ournal of Parenteral and Pharmaceutial Sciences
Product Description
This boo neatly clari>es some of the !ercei"ed !roblems surrounding contamination control in
!harmaceutical industry clean rooms. %t hel!s manufacturers satisfy both domestic and international
regulations and !re"ents their com!anies from suJering the conseAuences of non6com!liance. %t includes
u!6to6date information on microbiological contamination in sterile manufacturing, microbiological media
>lls, microbiological en"ironmental monitoring, control in aAueous6based, non6sterile !harmaceuticals,
ra!id testing methods, and clean room contamination control. This boo is a must for the microbiologist
&oring in !harmaceutical manufacturing. %DF STATL Dot yet !ublished
Product Details
Hardcover: 7.. !ages
Publisher: C?C Press- # edition /0une 7*,
7..82
Language: 3nglish
ISBN-!: .48$)7)..7
ISBN-": $546.48$)7)..)
Product Di#ensions: $.1 x *.8 x ..5
inches
Trou'leshooting HP)C ystems: * 5ench
0anual
Paul C. Sade /Author2
Product Description
A com!lete, u!6to6date guide to the use, maintenance, and troubleshooting of HP9C systems
The last t&enty6>"e years ha"e seen a dramatic rise in the use of High Performance 9iAuid
Chromatogra!hy /HP9C2 in laboratories &orld&ide. Troubleshooting HP9C Systems !ro"ides analysts as &ell
as laboratory technicians and managers &ith a readily accessible and immensely useful guide to the ne&
generation of HP9C eAui!ment and techniAues. +ith an em!hasis on eJecti"e troubleshooting of HP9C
systems, this lab com!anion co"ers system con>guration and functions, !roblem6sol"ing !rocedures,
maintenance, and HP9C basics. %t then &als chromatogra!hers in"estigating the source of a malfunction
through each system com!onent6from sol"ents and reser"oirs to sam!le !re!aration to columns and
detectors. S!ecial features of Troubleshooting HP9C Systems includeL
X A detailed re"ie& of HP9C instrumentation and accessories
X The role of o!erating !arameters as indicators of system !erformance
X Ste!6by6ste! troubleshooting !rotocols for each system com!onent
X Ho& to set u! a !re"enti"e maintenance !rogram for HP9C systems
X An o"er"ie& of the categories of HP9C se!arations
X A com!ilation of HP9C terms and de>nitions
X Tables and charts detailing sol"ents( !ro!erties
Product Details
Spiral-bound: ).* !ages
Publisher: +iley6%nterscience /Bctober 1,
#$$$2
Language: 3nglish
ISBN-!: .85##54)8$
ISBN-": $546.85##54)85
Product Di#ensions: $.7 x *.* x #.#
inches
!ood 0anufacturing Practices for
Pharmaceuticals, i1th "dition -Drugs
and the Pharmaceutical ciences.
[Hardcover]
=raham Bunn /Author2
Product Description
+ith global harmoni<ation of regulatory reAuirements and Auality standards and national and global
business consolidations ongoing at a fast !ace, !harmaceutical manufacturers, su!!liers, contractors, and
distributors are im!acted by continual change. BJering a &ide assortment of !olicy and guidance
document references and inter!retations, this Sixth 3dition is signi>cantly ex!anded to reKect the increase
of information and changing !ractices in C=MP regulation and !harmaceutical manufacturing and control
!ractices &orld&ide. An essential com!anion for e"ery !harmaceutical !rofessional, this guide is u!dated
and ex!anded by a team of industry ex!erts, each member &ith extensi"e ex!erience in industry or
academic settings.
Product Details
Publisher: %nforma Healthcare- * edition /:ecember
7*, 7..*2
Language: 3nglish
ISBN-!: .48$))$57)
ISBN-": $546.48$))$57#
Product Di#ensions: #..# x 5 x #.# inches
Hand'oo( of Pharmaceutical *nalysis 'y
HP)C, $olume A -eparation cience
and Technology. [Hardcover]
Satinder Ahuja /3ditor2
Product Description
High !ressure liAuid chromatogra!hySfreAuently called high !erformance liAuid chromatogra!hy /HP9C or,
9C2 is the !remier analytical techniAue in !harmaceutical analysis and is !redominantly used in the
!harmaceutical industry. +ritten by selected ex!erts in their res!ecti"e >elds, the Handboo, o(
Phar#aceutical %nal'sis b' HPL. /olu#e 0, !ro"ides a com!lete yet concise reference guide for
utili<ing the "ersatility of HP9C in drug de"elo!ment and Auality control. Highlighting no"el a!!roaches in
HP9C and the latest de"elo!ments in hy!henated techniAues, the boo ca!tures the essence of major
!harmaceutical a!!lications /assays, stability testing, im!urity testing, dissolution testing, cleaning
"alidation, high6through!ut screening,
X A com!lete reference guide to HP9C
X :escribes best !ractices in HP9C and oJers (trics of the trade( in HP9C o!eration and method
de"elo!ment
X ?e"ie&s ey HP9C !harmaceutical a!!lications and highlights currents trends in HP9C ancillary
techniAues, sam!le !re!arations, and data handling
Product Details
Hardcover: *.. !ages
Publisher: Academic Press- # edition /A!ril
#7, 7..12
Language: 3nglish
ISBN-!: .#7.44185*
ISBN-": $546.#7.44185)
%nited tates Pharmacopoeia ++ 2
8ational Formulary 6@
Author3
Anites States (har$aco#oeia Con"ention
Print /ersion
The Anited States (har$aco#oeia ?? ' %ational +or$ular <F (AS( ??'%+ <F) is a three'"olu$e co$bination of two official
co$#endia, the Anited States (har$aco#oeia (AS() and the %ational +or$ular (%+). AS('%+ is an annual #ublication, co$#rising
of one $ain #ublication and two su##le$ents each ear.
5n Januar <=B= AS( recalled AS( ??'%+ <F and subse:uentl reissued a re"ised #ublication in A#ril <=B=. (urchasers of the original
AS( ??'%+ <F will ha"e been sent the re"ised edition called AS( ??'%+ <F )eissue. %ew custo$ers will si$#l recei"e the official,
full re"ised reissue "ersion.
Custo$ers benefit fro$3
5ndi"iduall bound #rint co# of AS( ??'%+ <F )eissue %ew and )e"ised 7fficial Text Since the Second Su##le$ent to
AS( ?<'%+ <C
5ndi"iduall bound #rint co# of +irst Su##le$ent to the AS( ??'%+ <F )eissue
5ndi"iduall bound ()5%T co# of Second Su##le$ent to the AS( ??'%+ <F )eissue (June <=B=) -esigned to fit in
co$#act storage facilitit which co$es with the order.
C-')o$ features3
AS( ?<'%+ <C and its su##le$ents
AS( ??'%+ <F )eissue %ew and )e"ised 7fficial Text Since the Second Su##le$ent to AS( ?<'%+ <C
+irst Su##le$ent to the AS( ??'%+ <F )eissue
The AS( ??'%+ <F beco$es official on =B Ma <=B=. The +irst Su##le$ent is a"ailable fro$ +ebruar <=B= and beco$es official on
=B August <=B=. The Second Su##le$ent is a"ailable fro$ June <=B= and beco$es official on =B -ece$ber <=B=.
The AS('%+ #ro"ides access to official standards, enforceable b the A.S. +ood and -rug Ad$inistration for drugs and related
#roducts $anufactured and $arketed in the Anited States. 5n addition, the AS( ser"es as a clear ste#'b'ste# guide for the
s#ecifications ' tests, #rocedures, and acce#tance criteria ' re:uired for #har$aceutical $anufacturing and :ualit control.
AS( ??'%+ <F includes $ore than @<== $onogra#hs for drugs, exci#ients, biologics and dietar su##le$ents. The $onogra#h design
is in a new eas'to'read for$at with concise language. +or$at de"elo#$ents include3
Tests and #rocedures clearl designated in a logical flow
)eorganised contentE sub'headings reordered and rena$ed to $eet 5CH s#ecifications
Calculations ha"e been ex#anded to #ro"ide $ore detailsE added i$#urit tables and hea" $etal units u#dated to ##$
(re#aration of solutions are abbre"iated and a new strea$lined for$at used.
The AS('%+ is an essential #ublication for anone working in #har$aceuticals, biotechnolog, dietar su##le$ents, $edical de"ices
and gases and "eterinar drugs and is also is an i$#ortant reference for #har$acies, libraries, uni"ersities, and schools of $edicine
and #har$ac.
The #rint edition of AS('%+ is #rinted on a thick, durable #a#er stock suitable for laborator use. The !nglish edition is shi##ed in a
con"enient sli#case for eas access and storage.
The AS('%+ is a subscri#tion #roduct, with a fixed subscri#tion #eriod of %o"e$ber <==G to 7ctober <=B=.
1e' (eatures:
7fficial, full re"ised reissue
Co$#act storage case
(rint and user'friendl C-')7M co$bination #ackage
More than @,@== $onogra#hs
7"er <== general cha#ters co"ering general tests and assas
A new, eas'to'read for$at and $onogra#h laout
Hel#ful guides and charts that $ake it eas to find focus's#ecific infor$ation
!nsures co$#liance with official standards
!stablishes in'house standard o#erating #rocedures and s#ecifications
+acilitates new #roduct de"elo#$ent and a##ro"al.
E2ten
t
)
Folumes
Sub3 No
3
44!!
5
Si6e tbc Price Y517..
.
Bindi
ng
Hardbac
)re7ue
nc'
Annual
5ritish Pharmacopoeia 6:7: [Hardcover]
Stationery BIce /'. .2 /Author2
Product Description
Produced by the British Pharmaco!oeia Commission Secretariat, The British Pharmaco!oeia /BP2 7.#. is
the leading collection of standards for 'H medicinal !roducts and !harmaceutical substances. Do& used in
almost #.. countries, the BP remains an essential reference for all indi"iduals and organisations &oring
&ithin !harmaceutical research and de"elo!ment, manufacture, and testing across the globe. Hey
EeaturesL 9egally eJecti"e in the 'H from # 0anuary 7.#., 8. ne& monogra!hs for formulated
!re!arations, De& and re"ised monogra!hs for Herbal and Com!lementary Medicines &ithin their o&n
section in Folume %%%, Additional standards for &idely used unlicensed formulations, and 3uro!ean
Pharmaco!oeia *th edition material u! to and including Su!!lement *.1. 3uro!ean Pharmaco!oeia
monogra!hs are clearly distinguished and cross6referenced &hile a full index ensures easy access to the
current legally binding 'H standards.
Product Details
Hardcover: 1).. !ages
Publisher: Stationery BIce Boos /TSB2- # edition
/August #1, 7..$2
Language: 3nglish
ISBN-!: .##)774745
ISBN-": $546.##)774745
"uropean Pharmacopoeia AB: [Hardcover]
Council of 3uro!e /Cor!orate Author2
The Kth edition of the !uro#ean (har$aco#oeia ca$e into force on B Januar <==F and consists of a two'"olu$e $ain edition. 5t will
be u#dated on a regular basis with one su##le$ent following in 7ctober <==C, three in <==F and <==G, and the re$aining su##le$ent
in <=B= to create a collection of eight non'cu$ulati"e su##le$ents.
1e' (eatures:
7"er B,F== s#ecific and general $onogra#hs will be #ublished.
Contains all t#es of acti"e substances used to #re#are #har$aceutical #roducts3 "arious che$ical substances, antibiotics,
biological substances, "accines for hu$an or "eterinar use, 5$$unosera, )adio#har$aceutical #re#arations, herbal drugs
and ho$oe#ahtic #re#arations.
Also contains dosage for$s, general $onogra#hs, $aterials, containers and sutures.
Around <KF general $ethods with figures or chro$atogra$s.
7"er <<B= reagents will be described.
This #ublication is a"ailable in (rint, C-')7M and (ack for$at. Su##le$ents K.B, K.<, and K.? are a"ailable to bu se#aratel.
Su##le$ents K.?, K.@ and K.> are also a"ailable to bu as a #ack, #lease see below.
E2ten
t
8,)$7
!ages
ISBN 8498:940
!;50
Si6e 7#1 x
).7mm
Price Y71$...
Bindi
ng
Hardbac Publish
ed
7) 0ul 7..5
The ,nternational Pharmacopoeia
)ourth Edition
AuthorL
+orld Health Brgani<ation /+HB2
;The 5nternational (har$aco#oeia ' +ourth !dition; consolidates the texts of the fi"e se#arate "olu$es of the third edition. Certain
additions and a$end$ents ha"e been $ade to the notices in order to clarif the inter#retation of the (har$aco#oeia and to facilitate
a##lication of the re:uire$ents b the user.
This fourth edition will include all the $onogra#hs in the third edition together with new $onogra#hs for didanosine, indina"ir
sulfate, nelfina"ir $esilate, ne"ira#ine, ritona"ir, sa:uino"ir, sa:uino"ir $esilate. All the $onogra#h texts are brought together in one
section and the $ethod texts in another. !ach of these $aDor sections are di"ided into a##ro#riate sub'sections and the $ethod texts
are nu$bered for ease of cross'reference.
Method texts that ha"e been u#dated include, for exa$#le, the text on high #erfor$ance li:uid chro$atogra#h LH(.CM. This has
been re"ised to clarif certain technical ter$s and to add ad"ice on adDust$ent of chro$atogra#hic conditions, as reco$$ended b the
*H7 !x#ert Co$$ittee on S#ecifications for (har$aceutical (re#arations in 7ctober <==@.
E2ten
t
7 Folumes G #8$$
!ages
ISBN 8498:5;0
"!4
Si6e #*. x 78.mm Price Y7.....
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ed
74 Eeb 7..5
0artindale: The Complete Drug
3eference, +Ath "dition -6 $olume et.
[Hardcover]
Sean C. S&eetman /3ditor2
Product Description
This boo !ro"ides reliable, unbiased and e"aluated information on drugs and medicines used throughout
the &orld. 3ach ne& drug licensed for use has its o&n !otential bene>ts and ad"erse eJects, and its o&n
!ro>le for dosage, administration and indications. Eurthermore, manufacturers mae regular changes to
existing drug names and formulations, &hich can aJect their interactions and safe usage. Health
!rofessionals reAuire the correct ans&ers and need to ha"e con>dence in the drugs information they use 6
but &ith medicines e"ol"ing at this rate, ho& can they be sure their no&ledge is u! to dateZ ;Martindale;
contains u! to date information about more than 1,4.. substances. 3ach and e"ery entry is re"ie&ed by
our !harmaceutical editors to ensure health !rofessionals ha"e the most current data. Eormulations
change. :e>nitions change. Dames change. But you can al&ays trust ;Martindale;.
Product Details
Hardcover: )*$8 !ages
Publisher: Pharmaceutical Press- )* edition /March
#*, 7..$2
Language: 3nglish
ISBN-!: .41)*$48.*
ISBN-": $546.41)*$48.#
Product Di#ensions: #8.7 x #. x 1.7 inches
Capanese Pharmacopeia -Pharmacopoeia
of Capan. [Hardcover]
Uauji Di!!o 9td /Cor!orate Author2
Product Details
Hardcover: #544 !ages
Publisher: Maru<en Com!any, 9td.- #1 edition /March 7..*2
Language: 3nglish
ISBN-!: 848.4.$585
ISBN-": $546848.4.$58.
The 0erc( ,nde1: *n "ncyclopedia of
Chemicals, Drugs, and 5iologicals
[Hardcover]
Maryadele 0. B(Deil /3ditor2
Product Description
The $erc! %ndex is a one6"olume encyclo!edia of chemicals, drugs and biologicals that contains more than
#.,... monogra!hs. 3ach monogra!h in this authoritati"e reference source is a concise descri!tion of a
single substance or a small grou! of closely related com!ounds.
Compounds included:
N hu$an and "eterinar drugs
N biotech drugs and $onoclonal antibodies
N substances used for $edical i$aging
N biologicals and natural #roducts
N #lants and traditional $edicines
N nutraceuticals and cos$eceuticals
N agriculturals, #esticides and herbicides
N 7rganic che$icals used in research
N +ood additi"es and su##le$ents
N des, colors and indicators
N en"iron$entall significant substances
,nformation provided:
N che$ical, co$$on and generic na$es
N 7"er B>,=== trade$arks and associated co$#anies
N CAS )egistr %u$bers for o"er B<,=== co$#ounds
N 7"er F,>== che$ical structures
N $olecular for$ulae, weights and #ercentage co$#osition
N ca#sule state$ents identifing co$#ound classes and scientific significance
N scientific and #atent literature references
N #hsical and toxicit data
N thera#eutic and co$$ercial uses
N caution and ha0ard infor$ation
5n addition, there are $ore than C== new and co$#letel re"ised $onogra#hs, thousands of new references, trade$arks and uses
added to existing $onogra#hs. %ow includes a co$#anion C-')7M which features GFG $onogra#hs no longer a"ailable in #rint,
organic na$e reactions, su##le$ental tables and a new user interface for user'friendl searching.
+eatures of the C-3
Searchable by ey&ords, references, and numerical !ro!erties
Search the com!lete contents of the #8th edition, !lus nearly a thousand monogra!hs archi"ed
from !re"ious editions
Comes &ith a free one6year subscri!tion to the Merc %ndex %nternet 3dition
+indo&s6com!atible C: !o&ered by CambridgeSoft(s ChemEinder
3xtensi"ely re"ised su!!lemental tables no& including acronyms, "accines, and !hysical
constants
More than 5. !ages of hard to >nd information in one easy6to6use !lace
Product Details
Publisher: Merc- #8 edition /Do"ember ),
7..*2
Language: 3nglish
ISBN-!: .$##$#...T
ISBN-": $546.$##$#...#
.o#puter S'ste#s /alidation: &ualit'
%ssurance< Ris, =anage#ent< and
Regulator' .o#pliance (or
Phar#aceutical and Health
PublisherL %nforma HealthCare [ 7..)6#76#4 [ $*$ Pages [ %SBDL .48$)#45#4 [ P:E [ #).* MB
Both !er"asi"e and ubiAuitous, com!uteri<ed systems are no& an integral com!onent of e"ery cor!orate
strategy in !harmaceutical and healthcare com!anies. Ho&e"er, &hen technology is combined &ith high6
ris !ublic safety !rojects or the !roduction and control of life6sa"ing medicines or de"ices, it is necessary
to ensure that it is reliable, Auality assured, and "alidated. The most com!rehensi"e guide on com!uter
"alidation currently a"ailable, containing more than 7.. illustrations and more than #.. tables, Com!uter
Systems Falidation hel!s you see the big !icture.The author re"ie&s regulations and their de"elo!ment,
organi<ation res!onsibilities, "alidation life cycle based on =AMP8 =uide, strategic a!!roaches to
"alidation, electronic records and signatures, handling regulatory ins!ections, metrics, and o!!ortunities
for !erformance im!ro"ement. He !resents !ractical exam!les and checlists throughout the boo and
ex!lores the role of Auality assurance and ris management as ey com!onents of !ragmatic regulatory
com!liance. Co"ering methods that hel! you a"oid du!licating eJort among de!artments and business
functions, the boo demonstrates ho& you can use your in"estment in technology to im!ro"e business
eIciency and gain the com!etiti"e edge.
0ethod $alidation in Pharmaceutical
*nalysis: * !uide to 5est Practice
[Hardcover]
0oachim 3rmer
/3ditor2
Product Description
Ado!ting a !ractical a!!roach, the authors !ro"ide a detailed inter!retation of the existing regulations
/=MP, %CH2, &hile also discussing the a!!ro!riate calculations, !arameters and tests. The boo thus allo&s
readers to "alidate the analysis of !harmaceutical com!ounds &hile com!lying &ith both the regulations
as &ell as the industry demands for robustness and cost eJecti"eness.
+ollowing an introduction to the basic #ara$eters and tests in #har$aceutical "alidation, including s#ecificit, linearit, range,
#recision, accurac, detection and :uantitation li$its, the text focuses on a life'ccle a##roach to "alidation and the integration of
"alidation into the whole analtical :ualit assurance sste$. The whole is rounded off with a look at future trends.
*ith its first'hand knowledge of the industr as well as regulating bodies, this is an in"aluable reference for analtical che$ists, the
#har$aceutical industr, #har$aceutists, 4A officers, and #ublic authorities.
Product Details
Publisher: +iley6FCH- # edition /May $,
7..12
Language: 3nglish
ISBN-!: )175)#7117
ISBN-": $546)175)#711$
Product Di#ensions: $.* x 5 x # inches
Development and $alidation of *nalytical
0ethods, $olume + -Progress in
Pharmaceutical and 5iomedical *nalysis.
C.M. ?iley /Author
Product Description
The need to "alidate an analytical or bioanalytical method is encountered by analysts in the
!harmaceutical industry on an almost daily basis, because adeAuately "alidated methods are a necessity
for a!!ro"able regulatory >lings. +hat constitutes a "alidated method, ho&e"er, is subject to analyst
inter!retation because there is no uni"ersally acce!ted industry !ractice for assay "alidation. This boo is
intended to ser"e as a guide to the analyst in terms of the issues and !arameters that must be considered
in the de"elo!ment and "alidation of analytical methods. %n addition to the critical issues surrounding
method "alidation, this boo also deals &ith other related factors such as method de"elo!ment, data
acAuisition, automation, cleaning "alidation and regulatory considerations.
The book is di"ided into three #arts. (art 7ne, co$#rising two cha#ters, looks at so$e of the basic conce#ts of $ethod "alidation.
Cha#ter B discusses the general conce#t of "alidation and its role in the #rocess of transferring $ethods fro$ laborator to laborator.
Cha#ter < looks at so$e of the critical #ara$eters included in a "alidation #rogra$ and the "arious statistical treat$ents gi"en to these
#ara$eters.
(art Two (Cha#ters ?, @ and >) of the book focuses on the regulator #ers#ecti"e of analtical "alidation. Cha#ter ? discusses in so$e
detail how "alidation is treated b "arious regulator agencies around the world, including the Anited States, Canada, the !uro#ean
Co$$unit, Australia and Ja#an. This cha#ter also discusses the 5nternational Conference on Har$oni0ation (5CH) treat$ent of assa
"alidation. Cha#ters @ and > co"er the issues and "arious #ers#ecti"es of the recent Anited States "s. 9arr .aboratories 5nc. case
in"ol"ing the retesting of sa$#les.
(art Three (Cha#ters K ' B<) co"ers the de"elo#$ent and "alidation of "arious analtical co$#onents of the #har$aceutical #roduct
de"elo#$ent #rocess. This #art of the book contains s#ecific cha#ters dedicated to bulk drug substances and finished #roducts,
dissolution studies, robotics and auto$ated workstations, biotechnolog #roducts, biological sa$#les, analtical $ethods for cleaning
#rocedures and co$#uter sste$s and co$#uter'aided "alidation. !ach cha#ter goes into so$e detail describing the critical
de"elo#$ent and related "alidation considerations for each to#ic.
This book is not intended to be a #ractical descri#tion of the analtical "alidation #rocess, but $ore of a guide to the critical
#ara$eters and considerations that $ust be attended to in a #har$aceutical de"elo#$ent #rogra$. -es#ite the existence of nu$erous
guidelines including the recent atte$#ts b the 5CH to be i$#le$ented in BGGF, the #ractical #art of assa "alidation will alwas
re$ain, to a certain extent, a $atter of the #ersonal #reference of the analst or co$#an. %e"ertheless, this book brings together the
#ers#ecti"es of se"eral ex#erts ha"ing extensi"e ex#erience in different ca#acities in the #har$aceutical industr in an atte$#t to bring
so$e consistenc to analtical $ethod de"elo#$ent and "alidation.
Product Details
Hardcover: )*7 !ages
Publisher: Pergamon- # edition /0une #7,
#$$*2
Language: 3nglish
ISBN-!: ..4.875$74
ISBN-": $546..4.875$74
Product Di#ensions: $ x *.# x # inches
Computer *pplications in
Pharmaceutical 3esearch and
Development -/iley eries in Drug
Discovery and Development. [Hardcover]
Sean 3ins
/3ditor2
Product Description
A uniAue, holistic a!!roach co"ering all functions and !hases of !harmaceutical research and de"elo!ment
+hile there are a number of texts dedicated to indi"idual as!ects of !harmaceutical research and
de"elo!ment, this uniAue contributed &or taes a holistic and integrati"e a!!roach to the use of
com!uters in all !hases of drug disco"ery, de"elo!ment, and mareting. %t ex!lains ho& a!!lications are
used at "arious stages, including bioinformatics, data mining, !redicting human res!onse to drugs, and
high6through!ut screening. By !ro"iding a com!rehensi"e "ie&, the boo oJers readers a uniAue
frame&or and systems !ers!ecti"e from &hich they can de"ise strategies to thoroughly ex!loit the use of
com!uters in their organi<ations during all !hases of the disco"ery and de"elo!ment !rocess.
Cha!ters are organi<ed into the follo&ing sectionsL
X Com!uters in !harmaceutical research and de"elo!mentL a general o"er"ie&
X 'nderstanding diseasesL mining com!lex systems for no&ledge
X Scienti>c information handling and enhancing !roducti"ity
X Com!uters in drug disco"ery
X Com!uters in !reclinical de"elo!ment
X Com!uters in de"elo!ment decision maing, economics, and maret analysis
X Com!uters in clinical de"elo!ment
X Euture a!!lications and future de"elo!ment
3ach cha!ter is &ritten by one or more leading ex!erts in the >eld and carefully edited to ensure a
consistent structure and a!!roach throughout the boo. Eigures are used extensi"ely to illustrate com!lex
conce!ts and multifaceted !rocesses. ?eferences are !ro"ided in each cha!ter to enable readers to
continue in"estigating a !articular to!ic in de!th. Einally, tables of soft&are resources are !ro"ided in
many of the cha!ters.
This is essential reading for %T !rofessionals and scientists in the !harmaceutical industry as &ell as
researchers in"ol"ed in informatics and A:M3T, drug disco"ery, and technology de"elo!ment. The boo(s
cross6functional, all6!hases a!!roach !ro"ides a uniAue o!!ortunity for a holistic analysis and assessment
of com!uter a!!lications in !harmaceutics.
Product Details
Publisher: +iley6%nterscience /0une ).,
7..*2
Language: 3nglish
ISBN-!: .85#5)55$4
ISBN-": $546.85#5)55$5
* Programming in the Pharmaceutical
,ndustry [Paper'ac(]
0ac Shosta
/Author2
Product Description
At lastN A real6&orld reference guide for clinical trial SAS !rogramming, !aced &ith solutions that
!rogrammers can a!!ly to their day6to6day !roblems. :isco"er ey techniAues and tools a"ailable &ithin
Base SAS /including the macro language and P?BC SC92, SASG=?APH, and SASGSTAT that can be used to
resol"e many common issues in &oring &ith clinical trial data. Brgani<ed to reKect the statistical
!rogrammer(s &or Ko&, this user6friendly text begins &ith an introduction to the &oring en"ironment,
then !resents cha!ters on im!orting and massaging data into analysis data sets, !roducing clinical trial
out!ut, and ex!orting data. Faluable !lug6and6!lay !rogramming exam!les are !ro"ided throughout.
+hether you(re a no"ice seeing an introduction to SAS !rogramming for the !harmaceutical industry or a
junior6le"el !rogrammer ex!loring ne& a!!roaches to !roblem sol"ing, you(ll >nd a &ealth of !ractical
suggestions to hel! you shar!en your sills.
Product Details
Paperbac,: )*. !ages
Publisher: SAS Publishing- # edition
/Se!tember 7..12
Language: 3nglish
ISBN-!: #1$.855$)*
ISBN-": $546#1$.855$)$
9iAuid %nterfaces in Chemical, Biological,
and Pharmaceutical A!!lications
/Surfactant Science Series2
Alfred H. +achter /Author2
Product Description
A reference describing interfacial !henomena in chemistry, biology, !hysics and medicine, of liAuid
interfaces. %ncludes more the 5.. eAuations, 8). dra&ings and !hotogra!hs, 7,4.. references, and
contributions from more than *. international authors. Com!lete co"erage of surface chemistry and its
a!!lications in a "ariety of >elds.
Product Details
Publisher: C?C Press- #st edition /Eebruary
#1, 7..#2
Language: 3nglish
ISBN-!: .4785.815*
ISBN-": $546.4785.8151
HP)C 0ethods for 3ecently *pproved
Pharmaceuticals [Hardcover]
=eorge 9unn
/Author2
Product Description
An indis!ensable resource for busy researchers
Uour time is "aluable6too "aluable to s!end hunting through the technical literature in search of the right
HP9C assay techniAues for your !rojects. +ith HP9C Methods for ?ecently A!!ro"ed Pharmaceuticals, you(ll
Auicly identify and re!licate the ideal !rocedures for your !roject needs, &ithout ha"ing to refer to original
source !ublications. More of your time can then be s!ent in the lab, not the library.
Co"ering the rele"ant &orld literature through 7..), this boo !ics u! &here :r. 9unn(s acclaimed HP9C
Methods for Pharmaceutical Analysis left oJ. %t arms you &ith established HP9C assay techniAues for
hundreds of ne&ly a!!ro"ed drugs, as &ell as drugs for &hich assay methods &ere only recently
de"elo!ed. Combining detailed descri!tions of !rocedures &ith s!ecially annotated references, this
!ractical handboo gi"es youL
X HP9C methods for )$. commonly !rescribed !harmaceutical com!ounds
X Farious !rocedures for each drug listed together6maing it easy to mix and match for customi<ed
a!!roaches
X Methods for drugs in biological Kuids and for bul and formulated drugs
X Chemical structures, molecular &eights and formulas, and CAS ?egistry Dumbers
X Cross6references to The Merc %ndex
X ?etention times of other drugs that can be assayed using the same methods
Product Details
Publisher: +iley6%nterscience- # edition /A!ril
#4, 7..12
Language: 3nglish
ISBN-!: .85#**$8#1
ISBN-": $546.85#**$8#4
Pharmaceutical "1trusion Technology
-Drugs and the Pharmaceutical
ciences. [Hardcover]
%saac =hebre6Selassie
Editorial Reviews
Product Description
The only boo to bring together all technical information necessary to de"elo! and maret !harmaceutical
dosage forms that meet current Auality and regulatory reAuirements. Pro"ides in6de!th descri!tions and
analyses of the ey !arameters of extruders and extrusion !rocesses\highlighting the a!!licability of melt
extrusion in !harmaceutical drug de"elo!ment and !roduct manufacturing.
Product Details
Publisher: %nforma Healthcare- # edition /May
#, 7..)2
Language: 3nglish
ISBN-!: .47858.1.1
ISBN-": $546.47858.1.8
,nternational Pharmaceutical Product
3egistration [Hardcover]
A.C. Cart&right /3ditor2,
Product Description
This reference text for the !harmaceutical industry sets out the regulatory reAuirements of the authorities
of the major &orld maret. The editors identify major ey technical and scienti>c areas in any a!!lication
for mareting authori<ation.
Product Details
Hardcover: $*4 !ages
Publisher: %nforma Healthcare /A!ril
#$$82
Language: 3nglish
ISBN-!: .#)858$58T
ISBN-": $546.#)858$585
Pharmaceutical 0icro'iology [Paper'ac(]
+. B. Hugo
Product Description
Eormerly 'ni". of Dottingham, 'H. Text for !harmacy undergraduate students on microbiology as it relates
to !harmacy, such as mode of action of antibiotics or the manufacture and Auality control of
!harmaceutical agents. Pre"ious editionL c#$$7. Halftone illustrations. ?eferenced. Softco"er.
Product Details
Paperbac,: 1#. !ages
Publisher: +iley6Blac&ell- * edition /0uly #1,
#$$42
Language: 3nglish
ISBN-!: .*)7.8#$*T
ISBN-": $546.*)7.8#$*#
Pharmaceutical u'stances: yntheses,
Patents, *pplications
Axel Hleemann
Product Description
Pharmaceutical Substances is the ne&ly re"ised and ex!anded edition of ;Pharma<eutische +irstoJe; in
3nglish, co"ering o"er 7,#.. !harmaceutical com!ounds of interest to the chemical and !harmaceutical
industry. A"ailable in !rint and C:6?BM, Pharmaceutical Substances is designed to be a com!lete
reference guide to e"ery !harmaceutical com!ound of signi>cance. %t is essential as a >rst !oint of
reference not only for s!ecialists in drug chemistry but also for anyone in"ol"ed in the synthesis or use of
!harmaceuticals. All com!ounds are organi<ed al!habetically according to %DD standard, for added ease of
use the boo features three additional indexesL %ntermediates 3n<ymes, Microorganisms, Plants and Animal
Tissues Substance Classes The C:6?BM &ill allo& >eld, full text and index searching. %t includes a bro&se
function to allo& you to !eruse the data al!habetically by %DD. %t &ill be u!dated annually &ith 1. to #..
ne& com!ounds added each year.
Product Details
Publisher: Thieme Medical Publishers- 8th edition
/0anuary 7..#2
Language: 3nglish
ISBN-!: )#)1148.8*
ISBN-": $546)#)1148.8#
>ransport Processes in Phar#aceutical
S'ste#s ?Drugs and the Phar#aceutical
Sciences: a Series o( >e2tboo,s and
=onographs@
9. Amidon
Product Description
'ni". of Michigan, Ann Arbor. 3x!lains !harmaceutical trans!ort !henomena, demonstrating a!!lications
ranging from drug or nutrient u!tae into "esicle or cell sus!ensions, to heat and mass trans!ort in free<e6
drying and hygrosco!icity. Eor researchers.
Product Details
Publisher: %nforma Healthcare- #st edition /0anuary
#1, 7...2
Language: 3nglish
ISBN-!: .4785**#.1
ISBN-": $546.4785**#.4
,ndustrial Pharmaceutical 5iotechnology
[Hardcover]
Heinrich Hlefen<
Product Description
This "olume focuses on !harmaceutical biotechnology as a ey area of life sciences. The com!lete range of
conce!ts, !rocesses and technologies of biotechnology is a!!lied in modern industrial !harmaceutical
research, de"elo!ment and !roduction. The results of genome seAuencing and studies of biological6genetic
function are combined &ith chemical, micro6electronic and microsystem technology to !roduce medical
de"ices and diagnostic biochi!s. A multitude of biologically acti"e molecules is ex!anded by additional
no"el structures created &ith ne&ly arranged gene clusters and bio6catalytic chemical !rocesses.
De& organisational structures in the co6o!eration of institutes, com!anies and net&ors enable faster
no&ledge and !roduct de"elo!ment and immediate a!!lication of the results of research and !rocess
de"elo!ment.
This boo is the ideal source of information for scientists and engineers in research and de"elo!ment, for
decision6maers in biotech, !harma and chemical cor!orations, as &ell as for research institutes, but also
for founders of biotech com!anies and !eo!le &oring for "enture ca!ital cor!orations.
Product Details
Hardcover: )$) !ages
Publisher: +iley6FCH- # edition /May 5,
7..72
Language: 3nglish
ISBN-!: )1757$$$11
ISBN-": $546)1757$$$1$
*ffinity Capillary "lectrophoresis in
Pharmaceutics and 5iopharmaceutics
-Drugs and the Pharmaceutical
ciences. [Hardcover]
?einhard H.H. Deubert /3ditor2
Product Description
Martin69uther6'ni"ersity, Halle6+ittenberg, =ermany. Text !resents recent breathroughs and techniAues in
aInity ca!illary electro!horesis to measure and determine the !hysicochemical and thermodynamic
!arameters of drug com!ounds. BJers strategies to ex!lore and characteri<e interactions bet&een drugs.
Product Details
Hardcover: )48 !ages
Publisher: %nforma Healthcare- # edition /0anuary
#8, 7..)2
Language: 3nglish
ISBN-!: .4785.$1#$
ISBN-": $546.4785.$1#4
Pharmaceutical tress Testing: Predicting
Drug Degradation -Drugs and the
Ste"en +. Baertschi /3ditor2
Product Description
The >rst boo de"oted to the to!ic, this reference discusses the !redicti"e !o&er and limitations of current
stress testing strategies and em!hasi<es the critical role of stress testing in the determination of the
stability characteristics of !harmaceuticals6oJering an extensi"e com!ilation of drug degradation studies
from real6&orld exam!les in the literature.
Product Details
Publisher: %nforma Healthcare- # edition /0une
78, 7..12
Language: 3nglish
ISBN-!: .47858.7##
ISBN-": $546.47858.7#8
5ioavaila'ility and 5ioe#uivalance in
Pharmaceutical Technology [Paper'ac(]
Pal /Author2
BooL Bioavailabilit' %nd Bioe7uivalence In Phar#aceutical >echnolog'
AuthorL Pal
%SBDL 4#7)$##14.
Publishing :ateL :!!0-:-!
PublisherL .bs Publishers %nd Distributors
3ditionL st
Dumber of PagesL ;8
9anguageL English
Hand'oo( of 0icro'iological &uality
Control in Pharmaceuticals and
0edical Devices -Pharmaceutical
cience eries. [Hardcover]
?osamund M. Baird /3ditor2
Product Description
This boo &ill be a !ractical guide to techniAues used in microbial Auality assurance in the !harmaceutical
industry. %t aims to >ll the ga! in the literature bet&een food and medical microbiology techniAues boos.
Product Details
Publisher: C?C Press- # edition /August
#5, 7...2
Language: 3nglish
ISBN-!: .5848.*#8T
ISBN-": $546.5848.*#87
Hand'oo( of Pharmaceutical
0anufacturing Formulations, econd
"dition: -i12$olume et. [Hardcover]
Sarfara< H. Dia<i
Product Description
An authoritati"e and #ractical guide to the art and science of for$ulating drugs.
*ith thoroughl re"ised and ex#anded content, this Second Edition six'"olu$e set co$#iles "olu$es fro$ +-A %ew -rug
A##lications, #atent a##lications, and other sources of generic and #ro#rietar for$ulations to co"er the broad s#ectru$ of issues
concerning drug $anufacturing.
A $ust'ha"e collection for #har$aceutical $anufacturers, educational institutions, and regulator authorities, this set is an excellent
#latfor$ for drug co$#anies to bench$ark their #roducts and for generic co$#anies to for$ulate drugs co$ing off #atent.
As the largest reference on #har$aceutical for$ulations, this handbook also #ro"ides guidelines on how to file a%-As in the shortest
#ossible ti$e, hel#ing #har$aceutical co$#anies to cut costs in the areas of #har$aceutical research and de"elo#$ent.
-i"ided con"enientl into two #arts2regulator and $anufacturing guidelines, and for$ulations2each "olu$e in the set co"ers3
c=MP com!liance
!re6a!!ro"al ins!ections
stability and bioeAui"alence testing
!acaging commodity de"elo!ment
common diIculties in formulating drugs
changes to aD:As
Product Details
Hardcover: 7.$8 !ages
Publisher: %nforma Healthcare- 7 edition /Se!tember
7#, 7..$2
Language: 3nglish
ISBN-!: #87..4#.*)
ISBN-": $546#87..4#.*.
Product Di#ensions: #*.8 x #7.) x 4.1 inches
$alidation and &ualification in *nalytical
)a'oratories
9ud&ig Huber
/Author2
Product Description
This Second Edition discusses &ays to im!ro"e !harmaceutical !roduct Auality &hile achie"ing
com!liance &ith global regulatory standards. +ith com!rehensi"e ste!6by6ste! instructions, !ractical
recommendations, standard o!erating !rocedures /SBPs2, checlists, tem!lates, and gra!hics for easy
incor!oration in a laboratory. This title ser"es as a com!lete source to the subject, and ex!lains ho& to
de"elo! and im!lement a "alidation strategy for routine, non6routine, and standard analytical methods,
co"ering the entire eAui!ment, hard&are, and soft&are Auali>cation !rocess. %t also !ro"ides guidance on
Auali>cation of certi>ed standards, in6house reference materials, and !eo!le Auali>cation, as &ell as
internal and third !arty laboratory audits and ins!ections.
Product Details
Publisher: %nforma Healthcare- 7 edition /0uly
7), 7..52
Language: 3nglish
ISBN-!: .48$)47*5T
ISBN-": $546.48$)47*5)
Product Di#ensions: $ x *.# x ..4 inches
Hvac ystems Duct Design [Paper'ac(]
Smacna
Product Details
Paperbac,
Publisher: Sheet Metal , Air Conditioning- )rd edition /0une #$$.2
ISBN-!: $$$#*7)471
ISBN-": $546$$$#*7)471
Product Di#ensions: ##.7 x 4.4 x # inches
Pharmaceutical Sus!ensionsL Erom
Eormulation :e"elo!ment to
Manufacturing
Pharmaceutical Sus!ensionsL Erom
Eormulation :e"elo!ment to
Manufacturing PublisherL S!ringer [
PagesL )7) [ 7..$6#.6#* [ %SBD
#88#$#.4*5 [ 1 MB
The sus!ension dosage form has long been used for !oorly soluble acti"e ingredients for "arious
thera!eutic indications. :e"elo!ment of stable dis!ersions o"er the shelf life of the drug !roduct continues
to be a challenge on many fronts.
A good understanding of fundamentals of dis!erse systems is essential in the de"elo!ment of a suitable
!harmaceutical sus!ension. The de"elo!ment of sus!ension dosage form follo&s a "ery com!licated !ath.
The selection of the !ro!er exci!ients /surfactants, "iscosity im!arting agents etc.2 is im!ortant. The
!article si<e distribution in the >nished drug !roduct dosage form is a critical !arameter that signi>cantly
im!acts the bioa"ailability and !harmacoinetics of the !roduct. A!!ro!riate analytical methodologies and
instruments /chromatogra!hs, "iscometers, !article si<e analy<ers, etc.2 must be utili<ed to !ro!erly
characteri<e the sus!ension formulation. The de"elo!ment !rocess continues &ith a successful scale6u! of
the manufacturing !rocess. ?egulatory agencies around the &orld reAuire clinical trials to establish the
safety and eIcacy of the drug !roduct. All of this de"elo!ment &or should culminate into a regulatory
>ling in accordance &ith regulatory guidelines. Pharmaceutical Sus!ensions, in its organi<ation, follo&s the
de"elo!ment a!!roach used &idely in the !harmaceutical industry. The !rimary focus of this boo is on the
classical dis!erse system S !oorly soluble acti"e !harmaceutical acti"e dis!ersed in a suitable "ehicle.
Pharmaceutical Preformulation and
Formulation: * Practical !uide from
Candidate Drug election to
Commercial Dosage Form [Hardcover]
Mar =ibson /Author2
Product Description
+ritten by a !anel of ex!erts, this boo co"ers e"ery stage of drug de"elo!ment, from candidate drug
selection to commercial formulation. %t !ro"ides !ractical reference and !ragmatic guide on &hat studies
need to be undertaen, for &hat reasons, and at &hat ey stages of the drug de"elo!ment !rocess. =oing
beyond co"erage of !reformulation, the boo discusses bio!harmaceuticals, drug deli"ery, formulation,
and !rocess de"elo!ment as!ects of !roduct de"elo!ment. The contributing authors share their
ex!erience and ex!ertise in signi>cant cha!ters di"ided into three useful sectionsL Aiding Candidate :rug
Selection, 3arly :rug :e"elo!ment, and Erom Product :esign to Commercial :osage Eorm. Eeatures
Product Details
Hardcover: 1$* !ages
Publisher: %nforma Healthcare- # edition /August
#, 7..#2
Language: 3nglish
ISBN-!: #158$##7.#
ISBN-": $546#158$##7.*
Pharmaceutical Formulation
Development of Peptides and Proteins
-The Taylor 9 Francis eries in
9ars Ho"gaard /3ditor2,
Product Description
This com!rehensi"e "olume brings the diJerent as!ects of !e!tide and !rotein formulation into focus,
beginning &ith the fundamentals of the !roduction of !e!tides and !roteins, ranging from synthesis to
!rotein !uri>cation.
Product Details
Hardcover: 7)4 !ages
Publisher: C?C Press- # edition /:ecember
#*, #$$$2
Language: 3nglish
ISBN-!: .5848.581*
ISBN-": $546.5848.581)
* Programming in the Pharmaceutical
,ndustry [Paper'ac(]
0ac Shosta
/Author2
Product Description
At lastN A real6&orld reference guide for clinical trial SAS !rogramming, !aced &ith solutions that
!rogrammers can a!!ly to their day6to6day !roblems. :isco"er ey techniAues and tools a"ailable &ithin
Base SAS /including the macro language and P?BC SC92, SASG=?APH, and SASGSTAT that can be used to
resol"e many common issues in &oring &ith clinical trial data. Brgani<ed to reKect the statistical
!rogrammer(s &or Ko&, this user6friendly text begins &ith an introduction to the &oring en"ironment,
then !resents cha!ters on im!orting and massaging data into analysis data sets, !roducing clinical trial
out!ut, and ex!orting data. Faluable !lug6and6!lay !rogramming exam!les are !ro"ided throughout.
+hether you(re a no"ice seeing an introduction to SAS !rogramming for the !harmaceutical industry or a
junior6le"el !rogrammer ex!loring ne& a!!roaches to !roblem sol"ing, you(ll >nd a &ealth of !ractical
suggestions to hel! you shar!en your sills.
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/Se!tember 7..12
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ISBN-!: #1$.855$)*
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FreeDe2DryingE)yophiliDation Of
Pharmaceutical 9 5iological Products,
Third "dition -Drugs and the
Pharmaceutical ciences.
9ouis ?ey
Product Description
+ree0e dring, or lo#hili0ation, is a well established technolog used in the #reser"ation of nu$erous #har$aceutical and biological
#roducts. This highl effecti"e dehdration $ethod in"ol"es the re$o"al of water fro$ fro0en $aterials "ia the direct subli$ation of
ice. 5n recent ears, this #rocess has $et with $an changes, as ha"e the regulations that i$#act lo#hili0ation #ractices. This new
edition of +ree0e -ring6 .o#hili0ation of (har$aceutical and 9iological (roducts addresses these changes with u#dated and new
cha#ters on e$erging de"elo#$ents in lo#hili0ation technolog, research, and industr #rocedures. (ro"iding both a scientific and
industrial #ers#ecti"e, this co$#rehensi"e text is a "aluable resource for all those who use free0e dring technolog.
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#1, 7.#.2
Language: 3nglish
ISBN-!: #8)$47151.
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Pharmaceutical and 0edical *pplications
of 8ear2,nfrared pectroscopy
-Practical pectroscopy. [Hardcover]
3mil +. Ciurc<a
/Author2
Product Description
This boo discusses the theory, instrumentation, "alidation, and im!lementation of near6infrared
s!ectrosco!y for !harmaceutical and medical a!!lications. %t sho&cases a di"erse range of contem!orary
methods for the !roduction, screening, and analysis of ne& drug !roducts and !harmaceuticals. Presents
current a!!roaches in near6infrared s!ectrosco!y /D%?2 to monitor and control multi!le !hases of the drug
manufacturing !rocess.
%bout the %uthor
Cadrai Technologies, =oldens Bridge, De& Uor, 'SA 'nited States Pharmaco!eia, ?oc"ille, Maryland, 'SA
--This text refers to an alternate "ardcover edition.
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Publisher: C?C Press- # edition /Eebruary
4, 7..72
Language: 3nglish
ISBN-!: .4785$81)7
ISBN-": $546.4785$81)4
Pharmaceutical Chemical *nalysis:
0ethods for ,dentification and )imit
Tests
Ble Pedersen
/Author2
Product Description
Co$#lete, referenced infor$ation in an eas'to'use for$at
Man of the $onogra#hs in the Euro$ean harmaco$iea, the industr standard test for certain grou#s of ingredients and exci#ients,
do not describe the tests in full, but reference general $ethods based on test'tube che$istr. *hen a test fails, ou need to know what
went wrong, how it can be fixed, and how to con"ince 4AO4C that the tested $aterial is oka. This gi"es ou little ti$e to dig out the
rele"ant scientific literature, literature that is often so old it doesnPt show u# in an electronic search.
Making this knowledge easil accessible and directl a##licable to work in the lab, Pharmaceutical Chemical *nalysis: 0ethods
for )imit Tests and ,dentifications ex#lains the #ur#ose of these older tests, the che$istr in"ol"ed, and ha0ards to a"oid. The book
co"ers the identification of ions and functional grou#s tests and li$it tests res#ecti"el. 5t co"ers subDects rele"ant to all the
#har$aco#oeial identification6li$it test and then goes on to describe the indi"idual tests in cha#ters organi0ed and na$ed as the
a##ear in the Euro$ean harmaco$oeia. !ach cha#ter begins with a short discussion on the #ur#ose and rationale of the tests,
followed b a re"iew of the #hsical and che$ical characters of the target ion or co$#ound. The author describes the che$ical
background and logic of the indi"idual #rocedural ste#s of the test with for$ulas and reaction and #ro"ides ti#s on the strengths and
weaknesses of these techni:ues in ter$s of s#ecificit, ruggedness, and #otential #rocedural #itfalls.
Strict regulator re:uire$ents and econo$ic #ressures $ake the #har$aceutical industr understandabl reluctant to re#lace a test that
is si$#le, chea#, and #erfor$s well with ex#ensi"e, un"alidated instru$ental techni:ues. This resource bridges the ga# b #ro"iding
an in'de#th understanding of the #rinci#les behind the Euro$ean harmaco$oeia tests and how to use the$, sa"ing ou "aluable
#roduction ti$e.
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7..*2
Language: 3nglish
ISBN-!: .48$)#$54#
ISBN-": $546.48$)#$541
Pharmaceutical Drug *nalysis [Hardcover]
Ashutosh Har /Author2
Product Description
%n this s!eci>c context the remarable !roliferation of &indo&s6based com!uter soft&are stretched
o"er&helmingly to&ards instrument control, real time data handling abilities and the ultimate usage of
9aboratory %nformation Management Systems /9%MS2 are sur!risingly note&orthy. ;Pharmaceutical :rug
Analysis; in its !resent form essentially com!rise of six !arts containing in all thirty6t&o &ell6elaborated
cha!ters !redominantly dealing &ith the set of descri!ti"e analytical methodologies de"elo!ed to control
and assure the Auality of the >nal mareted !roduct- and, therefore, includes both Aualitati"e and
Auantitati"e methods of analysis to hel! in the identi>cation as &ell as !urity of the !roduct. The main
!ur!ose of this textboo is to discuss in an ex!licit and lucid manner se"eral of the ne&er methods that
no& >nd rather &ider a!!lication in the domain of !harmaceutical analysis. The basic !rinci!le of each
techniAue is critically treated &ith em!hasis on factors that directly aJect its !ro!er and judicious
a!!lication to "arious analytical !roblems. An in6de!th no&ledge of these !rinci!les, instrumentations,
modus o!erandi, ex!erimental !arameters, and sam!le !re!aration !rocedures in order to o!timi<e the
!erformance !rocedure of ty!ical assay of !harmaceutical secondary !roducts i.e., dosage forms,
calculations etc., along &ith cognate assays from the BIcial Com!endia ha"e been included !rofusely.
'ndergraduate and !ostgraduate students of !harmaceutical drug analysis, Auality assurance chemists,
industrial trainees, bul6drug !rofessionals and those in related disci!lines earnestly reAuiring a substantial
fundamental understanding and no&ledge of the subject &ill certainly >nd this a much needed suitable
com!ilation for reading and reference. The broad co"erage included in each of the selected analytical
techniAues &ould render ;Pharmaceutical :rug Analysis; to be an useful source of ideas, ins!iration for
research, and de"elo!ing ne&er !ractical solutions to !roblems in the e"er ex!anding >eld of
!harmaceutical analysis.
Product Details
Publisher: De& Age Publications /Academic2 /:ecember #, 7..*2
ISBN-!: 4#778#*584
ISBN-": $5464#778#*58$
8ame 3eactions and 3eagents in Organic
ynthesis [Hardcover]
Bradford P. Mundy
/Author2, Michael =. 3llerd /Author2, Eran =. Ea"aloro 0r. /Author2
Product Description
This Second 3dition is the !remier name resource in the >eld. %t !ro"ides a handy resource for na"igating
the &eb of named reactions and reagents. ?eactions and reagents are listed al!habetically, follo&ed by
rele"ant mechanisms, ex!erimental data /including yields &here a"ailable2, and references to the !rimary
literature. The text also includes three indices based on reagents and reactions, starting materials, and
desired !roducts. Brganic chemistry !rofessors, graduate students, and undergraduates, as &ell as
chemists &oring in industrial, go"ernment, and other laboratories, &ill all >nd this boo to be an
in"aluable reference.
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Hardcover: $.8 !ages
Publisher: +iley6%nterscience- 7 edition /A!ril
7#, 7..12
Language: 3nglish
ISBN-!: .85#77418.
ISBN-": $546.85#774185
Design and *nalysis of *nimal tudies in
Pharmaceutical Development
-Chapman 9 HallEC3C 5iostatistics
eries. [Hardcover]
Shein6Chung Cho& /3ditor2, 0en6!ei 9iu /3ditor2
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Language: 3nglish
ISBN-!: .4785.#).1
ISBN-": $546.4785.#).5
!0PE,O &uality *udit 0anual for
Healthcare 0anufacturers and their
uppliers, i1th "dition, -$olume 7 2 /ith
Chec(lis
9eonard Steinborn
/Author
Product Description
Folume # of this t&o6!art !acage !ro"ides a com!lete set of checlists for internal and contract de"ice
and drug manufacturers and de"elo!ers, contract soft&are de"elo!ers, and su!!liers of chemical, !rinted
material, electronic com!onent, and general su!!lies. %t also includes a simulated CS%T audit, and a ne&6
!roduct maret launch. All of these are referenced to the rele"ant rele"ant E:A regulations, 3C and %P3C
guidelines, and %SBGBS% standards. The text also ex!lains "arious audit ty!es, do(s and don(ts for auditors,
and guidance for audit !re!aration, !erformance, conclusion, re!ort deri"ation, and follo& u! acti"ities. A
C:6?BM !acaged &ith the boo contains all of the checlists in a customi<able electronic format.
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Publisher: %nforma Healthcare- * edition /0une
75, 7..)2
Language: 3nglish
ISBN-!: .48$)#48*5
ISBN-": $546.48$)#48*5
!0PE,O &uality *udit 0anual for
Healthcare 0anufacturers and Their
uppliers, i1th "dition -6 $olume et.:
!0PE,O &uality *udit 0anual for BBB
and !uidelines.: 3egulations $olume 6
[Paper'ac(]
9eonard Steinborn
-*uthor.
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Language 3nglish
ISBN-!: .48$)#4851
ISBN-": $546.48$)#4858
*dvanced Practical 0edicinal Chemistry
[Paper'ac(]
Ashutosh Har /Author2
%bout the %uthor
Ashutosh Har is a &ell6no&n Professor of Pharmaceutical Chemistry, !resently, teaching at Shri ?DS
College of Pharmacy, =ormi, Bhind /M.P.2. He has to his credit t&enty6se"en years teaching ex!erience at
undergraduate and graduate le"els both in %ndian 'ni"ersities and abroad. He has !ublished more than
t&enty research !a!ers based on !harmacological studies on natural and synthetic drugs in international
and national scienti>c journals. He has taught at School of Pharmacy, Addis Ababa 'ni"ersity, Addis Ababa
/3thio!ia2 /7..767..12- =uru 0hambhesh&ar 'ni"ersity, Hisar /%ndia2 /#$$$67..72- Al6Arab Medical
'ni"ersity, Bengha<i, /9ibya2 /#$$56#$$42- College of Pharmacy /'ni"ersity of :elhi2, :elhi /%ndia2 /#$$.6
#$$82- Eaculty of Pharmaceutical Sciences, 'ni"ersity of Digeria, Dsua /Digeria2 /#$5*6#$452.
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)., 7..$2
ISBN-!: 4#778#1)$)
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Chemical *nalysis in the )a'oratory: *
5asic !uide [Paper'ac(]
%. Mueller6Har"ey
-*uthor
Product Description
Pro"ides basic training in the &hole analytical !rocess for students, demonstrating &hy analysis is
necessary and ho& to tae sam!les, before they attem!t to carry out any analysis in the laboratory.
Softco"er.
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Paperbac,: ##7 !ages
Publisher: ?oyal Society of Chemistry- # edition
/Se!tember #., 7..72
Language: 3nglish
ISBN-!: .418.8*8*#
ISBN-": $546.418.8*8*#
Food "nergy 2 0ethods of *nalysis *nd
Conversion Factors [Paper'ac(]
5ernan -*uthor
Paperbac,
Publisher: Bernan Assoc /March 7..82
Language: 3nglish
ISBN-!: $71#.1.#85
5S9%'B?3 ?;@2?6F7:F:7G?
5ioanalytical eparations, $olume G
-Hand'oo( of *nalytical eparations.
Editorial Reviews
Review
;This is a &ell6&ritten and informati"e "olume. %t brings the reader u! to date on a &ide range of issues
!ertaining to se!aration methods in bioanalysis &ith s!ecial em!hasis on sam!le !re!aration and 9C6MS...
This boo should be of high "alue for scientists &oring &ith drug analysis in biological Kuids.;
lexander *e,lin+ The lchemist+ -ebruar# .//0.
Boo, Description
Folume 8 of the multi6"olume series, Handboo of Analytical Se!arations
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#5, 7..)2
Language: 3nglish
ISBN-!: .8881.*14*
ISBN-": $546.8881.*14.
*dvances in Chromatography
Edited by Phyllis R. Brown
Price: ]78$.$1
BindingA)or#at: Hardbac
ISBN: $546.647856$)*#6*
Publish Date: 0anuary 7.th #$$1
I#print: C?C Press
Pages: 884 !ages
Description
&1olu$e ?> exa$ines ti$el subDects such as #erfor$ance re:uire$ents, detection $odes, and ancillar techni:ues for o#tical
detectors in ca#illar electro#horesisE and $ore.&
Hand'oo( of ,solation and
CharacteriDation of ,mpurities in
Pharmaceuticals, $olume F -eparation
cience and Technology. [Hardcover]
atinder *huHa -*uthor., >aren 0ills *lsante -*uthor.
Product Description
The 'nited States Eood and :rug Administration /E:A2 and other regulatory bodies around the &orld
reAuire that im!urities in drug substance and drug !roduct le"els recommended by the %nternational
Conference on Harmonisation /%CH2 be isolated and characteri<ed.
%dentifying !rocess6related im!urities and degradation !roducts also hel!s us to understand the !roduction
of im!urities and assists in de>ning degradation mechanisms. +hen this !rocess is !erformed at an early
stage, there is am!le time to address "arious as!ects of drug de"elo!ment to !re"ent or control the
!roduction of im!urities and degradation !roducts &ell before the regulatory >ling and thus assure
!roduction of a high6Auality drug !roduct.
This boo, therefore, has been designed to meet the need for a reference text on the com!lex !rocess of
isolation and characteri<ation of !rocess6related /synthesis and formulation2 im!urities and degradation
!roducts to meet critical reAulatory reAuirements.
%t(s objecti"e is to !ro"ide guidance on isolating and characteri<ing im!urities of !harmaceuticals such as
drug candidates, drug substances, and drug !roducts. The boo outlines im!urity identi>cation !rocesses
and &ill be a ey resource document for im!urity analysis, isolationGsynthesis, and characteri<ation.
6 Pro"ides "aluable information on isolation and characteri<ation of im!urities.
6 =i"es a regulatory !ers!ecti"e on the subject.
6 :escribes "arious considerations in"ol"ed in meeting regulatory reAuirements.
6 :iscusses "arious sources of im!urities and degredation !roducts.
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Publisher: Academic Press- # edition /August
#, 7..)2
Language: 3nglish
ISBN-!: .#7.88$47T
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Drug2li(e Properties: Concepts, tructure
Design and 0ethods: from *D0" to
To1icity OptimiDation [Hardcover]
3d&ard Herns
/Author2, 9i :i
-*uthor.
Product Description
Bf the thousands of no"el com!ounds that a drug disco"ery !roject team in"ents and that bind to the
thera!eutic target, ty!ically only a fraction of these ha"e suIcient A:M3GTox !ro!erties to become a drug
!roduct. 'nderstanding A:M3GTox is critical for all drug researchers, o&ing to its increasing im!ortance in
ad"ancing high Auality candidates to clinical studies and the !rocesses of drug disco"ery. %f the !ro!erties
are &ea, the candidate &ill ha"e a high ris of failure or be less desirable as a drug !roduct. This boo is a
tool and resource for scientists engaged in, or !re!aring for, the selection and o!timi<ation !rocess.
The authors describe ho& !ro!erties aJect in "i"o !harmacological acti"ity and im!act in "itro assays.
%ndi"idual drug6lie !ro!erties are discussed from a !ractical !oint of "ie&, such as solubility, !ermeability
and metabolic stability, &ith regard to fundamental understanding, a!!lications of !ro!erty data in drug
disco"ery and exam!les of structural modi>cations that ha"e achie"ed im!ro"ed !ro!erty !erformance.
The authors also re"ie& "arious methods for the screening /high through!ut2, diagnosis /medium
through!ut2 and in6de!th /lo& through!ut2 analysis of drug !ro!erties.
X Ser"es as an essential &oring handboo aimed at scientists and students in medicinal chemistry
X Pro"ides !ractical, ste!6by6ste! guidance on !ro!erty fundamentals, eJects, structure6!ro!erty
relationshi!s, and structure modi>cation strategies
X :iscusses im!ro"ements in !harmacoinetics from a !ractical chemist(s stand!oint
Product Details
Publisher: Academic Press- # edition /Eebruary
#$, 7..42
Language: 3nglish
ISBN-!: .#7)*$17.#
ISBN-": $546.#7)*$17.4
Development of 5iopharmaceutical
Parenteral Dosage Forms -Drugs and
the Pharmaceutical ciences. [Hardcover]
Bontem!o /Author2
Product Description
This u!6to6the6minute reference delineates-in a systematic fashion-the a!!ro!riate, seAuential ste!s for
the formulation of safe, eJecti"e, stable, and maretable liAuid !arenteral bio!harmaceutical
!roducts-co"ering fundamentals and essential !ath&ays for each !hase as &ell as its !ur!ose, function,
and relation to other stages in the !roduct de"elo!ment !rocess. +ritten by ex!erts currently in"ol"ed in
state6of6the6art ad"ances in the !harmaceutical drug industry, :e"elo!ment of Bio!harmaceutical
Parenteral :osage Eorms details bio!harmaceuticals that are licensed or undergoing clinical de"elo!ment,
including genetically engineered cell and engineered "ectors in the fermentation !rocess describes
!uri>cation and characteri<ation techniAues for r:DA thera!eutics, discussing se"eral ty!es of unit
o!erations for isolation, !uri>cation, and characteri<ation considers !reformulation and formulation
reAuirements, such as !hysicochemical !ro!erties, drug deli"ery, stability studies !rograms,
deacti"ationGdenaturation routes, selection of com!atible exci!ients, and regulatory com!liance elucidates
basics of analytical techniAues, methods de"elo!ment, se!aration methods using chromatogra!hic and
electro!horetic techniAues, and bioacti"ity methods co"ering bioassays and immunoassays for Auantifying
the stability of biological acti"ity sho&s ho& to select the a!!ro!riate >lter for maximi<ing com!atibility
and minimi<ing adsor!tion and inacti"ation, examining to!ics from basic >ltration theories to future trends
re"ie&s the selection !rocess for com!atible elastomeric closures, analy<ing !hysical, chemical,
toxicological !ro!erties, !rotein adsor!tion on elastomeric surfaces, strategies to reduceGeliminate
adsor!tion, and s!eciali<ed containers for biotechnological a!!lications and moreN Eurnished &ith hel!ful
references, tables, and dra&ings, this !ractical guide is indis!ensable for !harmaceutical, medicinal, and
!rotein chemists- molecular biologists- !rocess engineers- !uri>cation scientists- bio!harmaceutical and
!harmaceutical formulators and !roduct de"elo!ers- Auality control, Auality assurance, and regulatory
com!liance !ersonnel- and u!!er6le"el undergraduate and graduate students in these disci!lines.
Product Details
Publisher: %nforma Healthcare- # edition /0uly
71, #$$52
Language: 3nglish
ISBN-!: .4785$$4#T
ISBN-": $546.4785$$4#*
*nalytical 0easurement Terminology:
Hand'oo( of Terms %sed in &uality
*ssurance of *nalytical 0easurement
-$alid *nalytical 0easurement. [Paper'ac(]
3. Prichard /Author2
Product Description
This uniAue handboo ex!lains the most commonly used terminology and !laces each term in context.
Conce!ts are described in a &ay that mae them meaningful to !ractitioners and in line &ith ^oIcial
de>nitions^ de"elo!ed by international organi<ations.
Product Details
Paperbac,: 4* !ages
Publisher: ?oyal Society of Chemistry- # edition
/Do"ember $, 7..#2
Language: 3nglish
ISBN-!: .418.888)8
ISBN-": $546.418.888)*

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