FDA《特定药物的生物等效性指导原则》长半衰期药物生物等效性指导原则介绍分析-郝瑞霞

[e-mail]《》1231.0500102.1000223．100050FDA《》。、、、、、、、FDA《》。FDA《》FDA。FDA。doi10.11669/cpj.2017.02.020Ｒ951A1001－2494201702－0167－04IntroductionandAnalysisofFDAIssuedGuidanceonBioequivalenceＲecommendationsforSpecificProd-uctsＲelatedwithLongHalf-lifeDrugsHAOＲui-xia1ZHUFeng-chang2LIUYing31．NorthChinaPharmaceuticalCo．Ltd．ShijiazhuangHebei0500102．Chi-nesePharmaceuticalAssociationBeijing100022China3．NationalInstitutesforFoodandDrugControlBeijing100050ChinaABSTＲACTOBJECTIVETostudyandanalyzeFDAissuedguidanceonBioequivalenceＲecommendationsforSpecificProductsrelatedwithlongHalf-lifedrugs.METHODSBioequivalenceＲecommendationsforSpecificProductsrelatedwithlongHalf-lifedrugswasanalyzedfrommultipleaspectsincludingbioequivalencestudydesignsselectionofbioequivalencesubjectsdosageselectionofreferenceproductsanalytestomeasurebioequivalencewaiveronmultiple-strengthproductsandimplementationoftheBiopharmaceu-ticsClassificationSystem.ＲESULTSBioequivalenceＲecommendationsforSpecificProductsissuedbyFDAaretofurtherfacilitatege-nericdrugproductavailabilityandtoassistgenericpharmaceuticalindustrywithidentifyingthemostappropriatemethodologyfordevel-opingdrugsandgeneratingevidenceneededtosupportANDAapprovalorreassessmentasanextensionandimplementtotheguidelineinvolvedintheaspectofbioequivalence.CONCLSUTIONBioequivalenceＲecommendationsforSpecificProductsissuedbyFDAwouldprovideinstructiveandpracticalassiststotheequivalenceassessmentofqualityandcurativeeffectforgenericproductsinChinasincethereisnotcorrespondingbioequivalenceguidanceonspecificlongHalf-lifedrugsreleasedbyCFDAyet.KEYWOＲDSLonghalf-lifedrugsbioequivalenceanalytestomeasurewaiversoptionsfromBEstudybioequivalenceBE1。。。24h。CmaxAUCFDA24hAUC2。FDA20106《》Bioequiv-alenceＲecommendationsforSpecificProducts3。2015FDA《·761·20171522ChinPharmJ2017JanuaryVol.52No.2》Product-SpecificＲecommendationsforGenericDrugDevelopment4。FDA《》FDA2013《》5。FDA《》。1FDAFDA20116。FDA《》451。289、、、、、、、。22.1FDA241h1FDA10mg200mg10/5mgEQ2.08mgBase1mg15mg2gm2mg250mg15mg100mg2mg200mg14mg300mg100mg50mg150mg50mg2mg0.5mg200mg1mg23mg40mg90mg0.5mgEq40mgbaseEQ20mgBaseEq20mgbase20mgEq20mgbase60mg28mg2.5mg10mg10mgEQ75mgbase10mg10mg100/20mg0.3mg35mg100mg150/35mg2h3。FDA《》。ＲEMS7。、、、“”8。2.2FDA《》24h4。2～3d。CmaxAUC。AUC0-72hAUC0-tAUC0-inf。AUC。FDA《》、、、、、、。。FDA、、48h9。2.3FDA·861·ChinPharmJ2017JanuaryVol.52No.2201715221818、602。《》、、、、、、、、。《》2。317FDA《》BEBEBE10。FDA3-4。FDA2/mg500.510014。200。100/20。1、。3pH1.24.56.8f23-4。FDA《》、、、、、、、、、、、、、、、、、、、、、、、、、。FDA2015《BA/BE》2010BCS3BA/BEBCS13API11-12。BCS。BCS1、HighSolubility-HighPermeabili-ty2、LowSolubility-HighPermeability3、HighSolu-bility-LowPermeability4、LowSolubility-LowPermeability10-11。BCSBCS13。4FDA。、2。FDA、、。4。FDA《》3。·961·20171522ChinPharmJ2017JanuaryVol.52No.23EQ75mgbaseE-10-15mgN-。。N-。0.5mg。100/20mgA771726。5。FDAFDA。14-15。FDA《》。6。FDA8。7。40d7。FDA《》、、、、、、。FDA《》。ＲEFEＲENCES1CFDA．GuidanceonBioequivalenceStudieswithPharmacokinet-icEndpointsforDrugsSubmittedUnderanANDAEB/OL．2016-5-182016-5-20．http//．sda．gov．cn/WS01/CL0087/147583．html．2U．S．CenterforDrugEvaluationandＲesearchCDEＲ．Guid-anceforIndustry．BioequivalenceStudieswithPharmacokineticEndpointsforDrugsSubmittedUnderanANDADraftGuidance2013EB/OL．2014-05-02．http//．fda．gov/down-loads/drugs/guidancecomplianceregulatoryinformation/guid-ances/ucm377465．pdf．3U．S．FDA．BioequivalenceＲecommendationsforSpecificProd-ucts2010EB/OL．2016-05-20．http//．fda．gov/downloads/drugs/guidancecomplianceregulatoryinformation/guid-ances/ucm072872．pdf．4U．S．FDA．Product-SpecificＲecommendationsforGenericDrugDevelopment2015EB/OL．2016-05-20．http//．fda．gov/drugs/guidancecomplianceregulatoryinformation/guid-ances/ucm075207．htm．5ZHUFCDINGLXWANGAGetal．Introductionandanal-ysisofguidanceforindustrybioequivalencerecommendationsforspecificproductsissuedbyFDAJ．ChinPharmJ201651181615-1621．6U．S．FDA．DraftGuidanceonAmiodaroneHydrochloride2010EB/OL．2016-07-05．http//．fda．gov/downloads/Drugs/GuidanceComplianceＲegulatoryInformation/Guidances/UCM238049．pdf7U．S．FDA．DraftGuidanceonClorazepateDipotassium2012EB/OL．2016-07-05．http//．fda．gov/downloads/Drugs/GuidanceComplianceＲegulatoryInformation/Guidances/UCM333046．pdf8U．S．FDA．DraftGuidanceonMemantineHydrochloride2012EB/OL．2016-07-05．http//．fda．gov/downloads/Drugs/GuidanceComplianceＲegulatoryInformation/Guidances/UCM296903．pdf9U．S．FDA．DraftGuidanceonLevothyroxineSodium2014EB/OL．2016-07-05．http//．fda．gov/downloads/Drugs/GuidanceComplianceＲegulatoryInformation/Guidances/UCM428208．pdf10CHENJCIntroductionofFDAAnnouncedBioavailabilityandbioequivalencestudiesfororallyadministereddrugproducts-gen-eralconsiderations2007EB/OL．2016-5-20．http//．cde．org．cn/dzkw．domethod=largePage＆id=24611U．S．FDA．GuidanceforindustryWaiverofininvobioequiva-lencestudiesforimmediate-releasesolidoraldosageformsbasedonaBiopharmaceuticsClassificationSystem2015EB/OL．2016-5-20．http//．fda．gov/downloads/drugs/guid-ancecomplianceregulatoryinformation/guidances/ucm070246．pdf12GAOYGENGLD．ComparisonanddiscussionofFDAWHOandEMAguidelinesonBCS-basedbiowaiverJ