Sample size determination in bioequivalence studies using statistical assurance-Reference-Cited by-同舟云学术

Sample size determination in bioequivalence studies using statistical assurance

Published:2019-08-13 Issue:10 Volume:85 Page:2369-2377
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Ring A.¹²^ORCID,Lang B.³,Kazaroho C.⁴^ORCID,Labes D.⁵^ORCID,Schall R.¹⁶^ORCID,Schütz H.⁷^ORCID

Affiliation:

1. University of the Free State Bloemfontein South Africa

2. medac Wedel Germany

3. Boehringer Ingelheim Biberach Germany

4. AIMS Rwanda Kigali Rwanda

5. Consultant Berlin Germany

6. IQVIA Biostatistics Bloemfontein South Africa

7. BEBAC Vienna Austria

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14055

Reference22 articles.

1. European Medicines Agency Guideline on the investigation of bioequivalence.2010.Doc. Ref. CPMP/EWP/QWP/1401/98 Rev. 1.

2. Food and Drug Administration.2014.Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations. Draft guidance.

3. Common noncompartmental pharmacokinetic variables: are they normally or log-normally distributed?

4. WHY ARE PHARMACOKINETIC DATA SUMMARIZED BY ARITHMETIC MEANS?

5. A comparison of the two one‐sided tests procedure and the power approach for assessing the equivalence of average bioavailability;Schuirmann DJ;Br J Clin Pharmacol,2019

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