Controlling type I error in the reference‐scaled bioequivalence evaluation of highly variable drugs-Reference-Cited by-同舟云学术

Controlling type I error in the reference‐scaled bioequivalence evaluation of highly variable drugs

Published:2019-06-12 Issue:5 Volume:18 Page:583-599
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Ocaña Jordi¹^ORCID,Muñoz Joel²^ORCID

Affiliation:

1. Department of Genetics, Microbiology and StatisticsUniversitat de Barcelona Barcelona Spain

2. Faculty of Physical and Mathematical Sciences, Department of StatisticsUniversity of Concepcion Concepcion Chile

Funder

Generalitat de Catalunya

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.1950

Reference24 articles.

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2. Conference report: Bio‐International 2005;Midha KK;J Pharm Sci,2007

3. Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence

4. EMA.Guideline on the Investigation of Bioequivalence. European Medicines Agency CPMP/EWP/QWP/1401/98 Rev.1/Corr. London.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf;2010.

5. FDA.Draft guidance on progesterone. The United States Food and Drug Administration: Rockville Maryland.www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm209294.pdf;2010.

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