Analysis of formulation similarity requirements for biowaiver of bioequivalence studies in multi-strength fixed-dose combinations by the European Medicines Agency
CHEN Si
MI Xianwei
SHI Jing
Abstract：This article systematically analyzed the requirements of the European Medicines Agency(EMA)for formu-lation similarity when applying for bioequivalence(BE)waivers for other specifications of multi-specification chemical compound pharmaceutical preparations,based on specifications that have already passed BE trials.The analysis was conduc-ted in accordance with Investigation of Bioequivalence-Scientific Guideline(Rev.1,2010)and clinical pharmacology and pharmacokinetics:questions and answers(Sections 6.4 and 6.5,2020-2021)issued by EMA.The findings aimed to provide scientific references for the development and registration of FDCs in domestic markets.
Keywords：EMAMulti-strength fixed-dose combinationsBiowaiver of bioequivalence studiesFormulation similarity requirements
Publication Date：2025-09-30
Online Publishing Date：2025-10-30(First online date of this platform, not the publication date of the document)
Pages：5( 877-881 )