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

Author:

Lee Jieon1,Feng Kairui1,Conti Denise S.1,Walenga Ross1,Wientjes Michael1,Wang Hezhen1,Newman Bryan1,Han Liangfeng1,Dhapare Sneha1,Bielski Elizabeth1,Babiskin Andrew1,Wu Fang1,Donnelly Mark1,Kim Myong‐Jin1,Jiang Wenlei1,Luke Markham C.1,Fang Lanyan1,Zhao Liang1

Affiliation:

1. Office of Research and Standards Office of Generic Drugs Center for Drug Evaluation and Research (CDER) US Food and Drug Administration (FDA) Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference35 articles.

1. U.S. Food and Drug Administration Center for Drug Evaluation and Research.bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an abbreviated new drug application. draft guidance for industry. Available from: (2021). Accessed January 27 2022.

2. International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences

3. Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products

4. U.S. Food and Drug Administration.Draft guidance on beclomethasone dipropionate. Recommended May 2019. Available from: (2019). Accessed January 27 2022.

5. U.S. Food and Drug AdministrationComparative analyses and related comparative use human factors studies for a drug‐device combination product submitted in an ANDA: draft guidance for industry. Available from: (2017). Accessed January 27 2022.

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