A two-stage procedure for bioequivalence studies
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Updated: Jul 31, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
A Racine-Poon1, A P Grieve, H Flühler
1Mathematical Applications, CIBA-GEIGY AG, Basel, Switzerland.
Abstract:
A two-stage experimental procedure for bioequivalence studies is proposed. The procedure is based on the idea that information from a first-stage experiment can be used to form a predictive distribution for the outcome of a second-stage experiment, thus permitting an assessment of the probability of a successful overall outcome. A systematic numerical study of a variety of possible strategies results in the identification of procedures that lead to substantial increases in efficiency compared with single-stage studies.
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