Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence

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.

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3