Management system of bioequivalence studies of generic drugs of the US FDA and its enlightenment to China
DU Dan
YANG Yue
Abstract：This article mainly summarizes the FDA management system of bioequivalence studies of generic drugs by using the literature analysis method,through consulting the FDA official website and the related literature.The FDA management system of bioequivalence studies of generic drugs is constantly updated and improved,and currently the FDA has a relatively scientific and comprehensive management system for bioequivalence studies of generic drugs.The management of bioequivalence studies of generic drugs in our country started late and develops slowly,and its systematicness,scientificity and professionality need to be improved.Our country should establish specialized agencies to review bioequivalence studies,follow scientific bioequivalent evaluation standard,improve the guidelines on bioequivalence studies,and clarify the requirement for data provided by bioequivalence studies,so as to perfect the management system of bioequivalence studies of generic drugs in our country.
Keywords：bioequivalencegenericsevaluationscienceguidance
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1729-1735 )