Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products

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Author/s:Lee, Jieon; Feng, Kairui; Conti, Denise; Walenga, Ross; Wientijes, Michael; Wang, Hezhen; Newman, Bryan; Han, Liangfeng; Dhapare, Sneha; Bielski, Elizabeth; Babiskin, Andrew; Wu, Fang; Donnelly, Mark; Kim, Myong-Jin; Jiang, Wenlei; Luke, Markham; Fang, Lanyan; Zhao, Liang

Date:11/01/2022

Journal:Clinical Pharmacology and Therapeutics

DOI:10.1002/cpt.2553