Properties of a Confirmatory Two-Stage Adaptive Procedure for Assessing Average Bioequivalence

Author:

Østerdal Marie Louise1,Raymond Kyle1,Pipper Christian Bressen23ORCID

Affiliation:

1. Department of Biostatistics, Leo Pharma A/S, Ballerup, Denmark;

2. Biostatistics OSCD & Outcomes 1, Novo Nordisk A/S, Soeborg, Denmark;

3. Department of Public Health, University of Southern Denmark, Odense, Denmark

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Reference14 articles.

1. Bioequivalence trials, intersection-union tests and equivalence confidence sets

2. Recursive Combination Tests

3. Genz, A., Bretz, F., Miwa, T., Mi, X., Leisch, F., Scheipl, F., and Hothorn, T. (2021), mvtnorm: Multivariate Normal and t Distributions. R package version 1.1-2. Available at https://CRAN.R-project.org/package=mvtnorm.

4. Optimal promising zone designs

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