Sample size recommendation for a bioequivalent study

There are clear guidelines and suggestions on the sample size and power calculation from health authorities (HA) for Bio equivalence (BE) studies in Healthy volunteers (HV). The suggested power is at least 80\% and type 1 error is 5\%. In real life situations, the clinical trials plan with more than...

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Bibliographic Details
Main Authors: Chandrasekhar Bhupathi, Venakata HaraGopal Vajjha
Format: Article
Language:English
Published: University of Bologna 2017-04-01
Series:Statistica
Subjects:
Online Access:https://rivista-statistica.unibo.it/article/view/6699