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1、HandbookofStabilityTestinginPharmaceuticalDevelopmentKimHuynh-BaEditorHandbookofStabilityTestinginPharmaceuticalDevelopmentRegulations,Methodologies,andBestPractices123EditorKimHuynh-BaPharmalytikNewark,Delawarekim.huynhba@pharmalytik.comISBN:978-0-387-85626-1e-ISBN:978-0-387-
2、85627-8DOI10.1007/978-0-387-85627-8LibraryofCongressControlNumber:2008940845cSpringerScience+BusinessMedia,LLC2009Allrightsreserved.Thisworkmaynotbetranslatedorcopiedinwholeorinpartwithoutthewrittenpermissionofthepublisher(SpringerScience+BusinessMedia,LLC,233SpringStreet,New
3、York,NY10013,USA),exceptforbriefexcerptsinconnectionwithreviewsorscholarlyanalysis.Useinconnectionwithanyformofinformationstorageandretrieval,electronicadaptation,computersoftware,orbysimilarordissimilarmethodologynowknownorhereafterdevelopedisforbidden.Theuseinthispublication
4、oftradenames,trademarks,servicemarks,andsimilarterms,eveniftheyarenotidenti?edassuch,isnottobetakenasanexpressionofopinionastowhetherornottheyaresubjecttoproprietaryrights.Whiletheadviceandinformationinthisbookarebelievedtobetrueandaccurateatthedateofgoingtopress,neithertheaut
5、horsnortheeditorsnorthepublishercanacceptanylegalresponsi-bilityforanyerrorsoromissionsthatmaybemade.Thepublishermakesnowarranty,expressorimplied,withrespecttothematerialcontainedherein.Printedonacid-freepaperspringer.comAdreamyoudreamaloneisonlyadreamAdreamyoudreamtogetherisr
6、ealityJohnLennonPrefaceInmyprofessionalcareerasapharmaceuticalscientist,Ihavebeeninvolvedwithseveralaspectsofthedrugdevelopmentprocessfrompre-INDtocommercializationand,somehow,Iusuallyfoundmyselfcomingbacktoastability-relatedissue.Thestabilityareaseemedtodrawmyutmostinterestbe
7、causeinmyday-to-daywork,myopportunitiesinvolvedmorethanoneproduct,andnoneoftheissueswerethesame.Eachsituationposedchallengesthatusuallyrequiredanexerciseofjudgment,anunderstandingofregulations,aknowledgeofscience,agraspofcompliance,andanappreciationofcommonpractices.Sinceearly
8、2000,Ihavealsobeeninvolvedwithseveraltrainingopportunitiesand
