Comparison of average, scaled average, and population bioequivalence methods for assessment of highly variable drugs: An experience with doxifluridine in beagle dogs-Reference-Cited by-同舟云学术

Comparison of average, scaled average, and population bioequivalence methods for assessment of highly variable drugs: An experience with doxifluridine in beagle dogs

Published:2010-01 Issue:1-3 Volume:39 Page:175-180
ISSN:0928-0987
Container-title:European Journal of Pharmaceutical Sciences
language:en
Short-container-title:European Journal of Pharmaceutical Sciences

Author:

Baek In-hwan,Lee Byung-yo,Kang Wonku,Kwon Kwang-il

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference30 articles.

1. Benet, L.Z., 2006. Therapeutic Considerations of Highly Variable Drugs. Meeting of FDA Committee for Pharmacutical Science. http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_2_files/frame.htm (accessed April 4, 2007).

2. Advantages of a steady-state crossover design in assessment of bioequivalence of highly variable drugs: propafenone;Blume;Eur. J. Pharm. Sci.,1994

3. An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs;Boddy;Pharm. Res.,1995

4. Bioequivalence of a highly variable drug: an experience with nadolol;Buice;Pharm. Res.,1996

5. Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications;Davit;AAPS J.,2008

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