Author: Lee, Jieon; Feng, Kairui; Xu, Mingjiang; Gong, Xiajing; Sun, Wanjie; Kim, Jessica; Zhang, Zhen; Wang, Meng; Fang, Lanyan; Zhao, Liang
Title: Applications of Adaptive Designs in Generic Drug Development. Cord-id: dgcju55s Document date: 2020_9_17
ID: dgcju55s
Snippet: The possibilities of stopping a clinical study earlier based on interim study results or to adjust the sample size during the study conduct are attractive features of adaptive clinical study designs. Herein, we present a survey summary of bioequivalence (BE) studies with adaptive designs in abbreviated new drug applications (ANDAs), reflecting the current status of its utility in generic drug development.
Document: The possibilities of stopping a clinical study earlier based on interim study results or to adjust the sample size during the study conduct are attractive features of adaptive clinical study designs. Herein, we present a survey summary of bioequivalence (BE) studies with adaptive designs in abbreviated new drug applications (ANDAs), reflecting the current status of its utility in generic drug development.
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