Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products-Reference-Cited by-同舟云学术

Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products

Published:2016-05-16 Issue:4 Volume:18 Page:1032-1038
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Choi Stephanie H.,Lionberger Robert A.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-016-9932-z.pdf

Reference38 articles.

1. Peters JR, Hixon DR, Conner DP, Davit BM, Catterson DM, Parise CM. Generic drugs—safe, effective, and affordable. Dermatol Ther. 2009;22(3):229–40.

2. Title 21 code of federal regulations 320.1(e).

3. CDER/FDA. Guidance for industry: bioequivalence recommendations for specific products. 2010.

4. FDA. Product-specific recommendations for generic drug development. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm .

5. Title 21 code of federal regulations 314.94(a)(9)(iv)

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