Statistical considerations and impact of the FDA draft guidance for assessing adhesion with transdermal delivery systems and topical patches for ANDAs-Reference-Cited by-同舟云学术

Statistical considerations and impact of the FDA draft guidance for assessing adhesion with transdermal delivery systems and topical patches for ANDAs

Published:2019-09-03 Issue:5 Volume:29 Page:952-970
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Sun Wanjie¹,Grosser Stella¹,Kim Carol²,Raney Sam G.³

Affiliation:

1. Office of Biostatistics, Division of Biometrics VIII, U.S. Food and Drug Administration, Silver Spring, MD, USA

2. Office of Generic Drugs, Office of Bioequivalence, Division of Clinical Review, U.S. Food and Drug Administration, Silver Spring, MD, USA

3. Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, U.S. Food and Drug Administration, Silver Spring, MD, USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2019.1657440

Reference18 articles.

1. Controversial Statistical Issues in Clinical Trials

2. Adhesive Backing Foil Interactions Affecting the Elasticity, Adhesion Strength of Laminates, and How to Interpret These Properties of Branded Transdermal Patches

3. FDA Draft Guidance for Industry. 2016. Assessing adhesion with transdermal delivery systems and topical patches for ANDAs. Available from: https://www.fda.gov/media/98634/download.

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