FDA关于ANDA强制降解试验的观点-英文版

《FDA关于ANDA强制降解试验的观点-英文版》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。

1、Peer-reviewed:regulatoryScientificConsiderationsofForceddegradationStudiesinaNdaSubmissionsragineMaheswaranaBStraCtprovidesomeinformationwithrespecttodifferentawell-designedstressstudycanprovideinsightinchoos-stressconditionsofvariousdrugsubstances(3).ing

2、theappropriateformulationforaproposedproducttheforceddegradationinformationprovidedinthepriortointensiveformulationdevelopmentstudies.itabbreviatednewdrugapplication(aNda)submissionscanpreventre-developmentorre-validationofastabil-isoftenincompleteandinth

3、osecasesdeficienciesareityindicatinganalyticalmethod.thispaperoutlinescited.anoverviewofcommondeficienciescitedthrough-thescientificaspectsofforceddegradationstudiesthatoutthechemistry,manufacturing,andcontrols(CMC)shouldbeconsideredinrelationtoaNdasubmis

4、sions.sectionoftheaNdashasbeenpublished(4-6).SomeexamplesofcommonlyciteddeficienciesrelatedtoforcediNtroduCtioNdegradationstudiesincludethefollowing:Forceddegradationissynonymouswithstresstest-•yourdrugsubstancedoesnotshowanydegrada-ingandpurposefuldegrad

5、ation.Purposefuldegra-tionunderanyofthestressconditions.Pleasedationcanbeausefultooltopredictthestabilityofrepeatstressstudiestoobtainadequatedegra-adrugsubstanceoradrugproductwitheffectsondation.ifdegradationisnotachievable,pleasepurity,potency,andsafety

6、.itisimperativetoknowprovideyourrationale.theimpurityprofileandbehaviorofadrugsubstance•Pleasenotethattheconditionsemployedforundervariousstressconditions.Forceddegradationstressstudyaretooharshandthatmostofyouralsoplaysanimportantroleinthedevelopmentofdr

7、ugsubstancehasdegraded.Pleaserepeatyouranalyticalmethods,settingspecifications,anddesignstressstudiesusingmilderconditionsorshorterofformulationsunderthequality-by-design(Qbd)exposuretimetogeneraterelevantdegradationparadigm.thenatureofthestresstestingdep

8、endsonproducts.theindividualdrugsubstanceandthetypeofdrug•itisnotedthatyouhaveanalyzedyourstressedproduct(e.g.,solidoraldosage,lyophilizedpowders,samplesaspertheassaymethodconditions.andliquidformulations)involved(1