Author:
Bodenlenz Manfred,Tiffner Katrin I.,Raml Reingard,Augustin Thomas,Dragatin Christian,Birngruber Thomas,Schimek Denise,Schwagerle Gerd,Pieber Thomas R.,Raney Sam G.,Kanfer Isadore,Sinner Frank
Funder
U.S. Food and Drug Administration
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology
Reference27 articles.
1. Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol. 2013;14(1):1.
2. FDA. Guidance for industry: statistical approaches to establishing bioequivalence. Rockville: Center for Drug Evaluation and Research, Food and Drug Administration, FDA; 2001.
3. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15(6):657–80.
4. FDA. Guidance for industry: topical dermatological corticosteroids: in vivo bioequivalence, division of bioequivalence. Rockville: Center for Drug Evaluation and Research. Food and Drug Administration, FDA; 1995.
5. Kanfer I. Methods for the assessment of bioequivalence of topical dosage forms: correlations, optimization strategies and innovative approaches. In: Jenner J, Shah VP, Maibach HI, editors. Topical drug bioavailability, bioequivalence and penetration. 2nd ed. New York: Springer Science; 2015.
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