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当前位置:首页 > 行业资料 > 行业资料 > 生物化工 > 比较等效药品选择指南Guidance on the selection of comparator pharmacetical products for equivalence assessment

比较等效药品选择指南Guidance on the selection of comparator pharmacetical products for equivalence assessment

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  • 2020-11-10 21:49:08
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185Annex8Guidanceontheselectionofcomparatorpharmaceuticalproductsforequivalenceassessmentofinterchangeablemultisource(generic)products1.Introduction1862.Background1863.Generalprinciples188References189186WHOTechnicalReportSeriesNo.992,2015WHOExpertCommitteeonSpecificationsforPharmaceuticalPreparationsForty-ninthreport1.IntroductionInrecentyearstheneedfortheregulationandassuranceofqualityofmedicineshascontinuedtoincrease.Largenumbersofmultisource(generic)medicinesarebeingproducedbymanydifferentcompaniesandindifferentcountries;thismayresultindifferentproducts.Onagloballevelthereisthusaneedtoaddressnotonlythequality,safetyandefficacyofmultisourceproductsthatareexportedandimported,butalsotheirpossibleinterchangeability.Inlightofthevariousapproachesinscientificandregulatoryenvironments,thefeasibilityofdevelopingasystemofinternationalcomparatorproductswasconsideredinthepast.Thisinitiativeledtotherecommendationspublishedin2002entitled,Guidanceontheselectionofcomparatorpharmaceuticalproductsfo

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