Bayesian Approach to Establish Bioequivalence: Why and How?-Reference-Cited by-同舟云学术

Bayesian Approach to Establish Bioequivalence: Why and How?

Published:2019-01-21 Issue:2 Volume:105 Page:301-303
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Peck Carl C.¹²^ORCID,Campbell Gregory³⁴

Affiliation:

1. Department of Bioengineering and Therapeutic SciencesUniversity of California San Francisco California USA

2. NDA Partners LLC San Luis Obispo California USA

3. GCStat Consulting, LLC Silver Spring Maryland USA

4. NDA Partners LLC Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1288

Reference10 articles.

1. A History of Biopharmaceutics in the Food and Drug Administration 1968–1993

2. A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability

3. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER).Guidance for industry: statistical approaches to establishing bioequivalence(2001).https://www.fda.gov/downloads/drugs/guidances/ucm070244.pdf.

4. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health.Guidance for industry and FDA staff: guidance for the use of Bayesian statistics in medical device clinical trials(2010).https://www.fda.gov/MedicalDevices/ucm071072.htm.

5. On Bayesian Methods for Bioequivalence

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