Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products-Reference-Cited by-同舟云学术

Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products

Published:2014-10-25 Issue:1 Volume:17 Page:121-133
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Braddy April C.,Davit Barbara M.,Stier Ethan M.,Conner Dale P.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-014-9679-3.pdf

Reference63 articles.

1. Shah VP. Progress in methodologies for evaluating bioequivalence of topical formulations. Am J Clin Dermatol. 2001;2(5):275–80.

2. Kanfer I. Strategies for the bioequivalence assessment of topical dermatological dosage forms. J Bioequivalence Availab. 2010;2:102–10. doi: 10.4172/ jbb.1000040 .

3. Kircik LH, Bikowski JB, Cohen DE, Draelos ZD, Hebert A. Formulation development, testing and approval, part 1 of 2. Supplement to practical dermatology. Vehicles matter. 2010. http://bmctoday.net/vehiclesmatter/pdfs/0310.pdf . Accessed 18 Apr 2014.

4. General Chapter <1151> Pharmaceutical dosage forms. US Pharmacoepia. 2013. http://www.uspnf.com/uspnf/pub/index?usp=36&nf=31&s=2&officialOn=December 1, 2013 . Accessed 18 April 2014.

5. Shah VP, Flynn GL, Yacobi A, Maibach HI, Bon C, et al. Bioequivalence of topical dermatological dosage forms—methods of evaluation of bioequivalence. Pharm Res. 1998;15(2):167–71. doi: 10.1023/A:1011941929495 .

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