Experience Learned and Perspectives on Using Model Integrated Evidence in the Regulatory Context for Generic Drug Products

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Author/s:Tsakalozou, Eleftheria; Fang, Lanyan; Bi, Youwei; Van Den Heuvel, Michiel; Ahmed, Tausif; Tsang, Yu Chung; Lionberger, Robert; Rostami-Hodjegan, Amin; Zhao, Liang

Date:

Journal:The AAPS Journal

DOI:10.1208/s12248-023-00884-5