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1、dx.doi.org/10.14227/DT180111P31BiopharmaceuticsClassificationSystem:ARegulatoryApproachB.BasantaKumarReddy1,*andA.Karunakar2e-mail:bbasanthdreddy@gmail.com1RegulatoryAffairDpt.,IndchemieHealthSpecialitiesPvt.Ltd.,(AlkemResearchLaboratory),M.I.D.C,Taloja,Dist-Raigarh,NaviMumbaiMaharashtra-410208,
2、India2RegulatoryAffairDepartment,IPDO,Dr.Reddy’sLaboratory,Bachupally,Hyderabad,AndhraPradesh-502325,IndiaABSTRACTTheBiopharmaceuticsClassificationSystem(BCS)istheresultofcontinuouseffortsinmathematicalanalysisfortheelucidationofthekineticsanddynamicsofthedrugprocessinthegastrointestinaltract(GI
3、T)forNDA(NewDrugApplication)andANDA(AbbreviatedNewDrugApplication)filingsandbiowaivers.Thisstepreducestimelinesinthenewdrugdevelopmentprocess,bothdirectlyandindirectly,reducesunnecessarydrugexposureinhealthyvolunteers,andincreasesimpactforthereplacementofcertainbioequivalence(BE)studieswithinvit
4、rodissolutiontests.INTRODUCTIONOBJECTIVESANDCONCEPTOFBCSnANDA(21CFR314)containsdataforthereviewTheobjectivesoftheBCSare(2):Aandultimateapprovalofagenericdrugproduct.•ToimprovetheefficiencyofthedrugdevelopmentGenericdrugapplicationsaretermed“abbreviated”andreviewprocessbyrecommendingastrategyforb
5、ecausetheygenerallyarenotrequiredtoincludeidentifyingexpendableclinicalbioequivalencetest.preclinical(animal)andclinical(human)datatoestablish•Torecommendaclassofimmediate-release(IR)solidsafetyandeffectiveness.Instead,genericapplicantsmustoraldosageformsforwhichbioequivalencemaybescientifically
6、demonstratethattheirproductsareassessedbasedoninvitrodissolutiontests.bioequivalent(i.e.,performsinthesamemannerasthe•Torecommendmethodsforclassificationaccordinginnovatordrug).todosageformdissolutionalongwiththesolubility–Bioequivalencestudiesareconductedongenericdrugpermeabilitycharacteristics
7、ofthedrugproduct.productsinplaceofanimalstudies,clinicalstudies,orTheBCS,whichisbasedonscientificprinciples,presentsbioavailabilitystudies.Invitro–invivocorrelation(IVIVC)anewparadigminbioequivalence.Accordingtothestudiescan
