Algorithms for evaluating reference scaled average bioequivalence: power, bias, and consumer risk-Reference-Cited by-同舟云学术

Algorithms for evaluating reference scaled average bioequivalence: power, bias, and consumer risk

Published:2017-08-29 Issue:27 Volume:36 Page:4378-4390
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statistics in Medicine

Author:

Tothfalusi Laszlo¹^ORCID,Endrenyi Laszlo²

Affiliation:

1. Department of Pharmacodynamics; Semmelweis University; Budapest Hungary

2. Department of Pharmacology and Toxicology; University of Toronto; Toronto Ontario Canada

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference31 articles.

1. Evaluation of the bioequivalence of highly-variable drugs and drug products;Tothfalusi;Pharm Res,2001

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

3. Bioequivalence approaches for highly variable drugs and drug products;Haidar;Pharm Res,2008

4. European Medicines Agency Guideline on the investigation of bioequivalence London, United Kingdom 2010 http://www.ema.europa.eu/docs/en_GB/document_library//2010/01/WC500070039.pdf

5. Limits for the scaled average bioequivalence of highly variable drugs and drug products;Tothfalusi;Pharm Res,2003

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