In August 2023, the European Federation of Pharmaceutical Sciences (EUFEPS) and the American Association of Pharmaceutical Scientists (AAPS) successfully held the fifth Global Bioequivalence Harmonization Initiative (GBHI) conference, bringing together professionals from all over the world. This meeting conducted an in-depth discussion on promoting the harmonization of global bioequivalence assessment standards. The meeting provided a comprehensive discussion of the appropriateness and potential benefits of in vitro testing as an alternative to clinical efficacy studies, moving toward a unified standard for bioequivalence assessment. The meeting aimed to find an optimal coordination strategy to increase consistent approval rates across agencies, minimize inconsistencies with past approved products, and reduce consumer risk. Bioequivalence (BE) testing is of great significance to the development of new drugs. The BE test is a method of studying...
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