
We show that correct statistical inference from simulated virtual clinical trials requires a Bayesian framework. Simulating frequentist test procedures degrades the prior information contained in the model. We demonstrate the application of a Bayesian workflow to PBPK-simulated virtual bioequivalence trials. The workflow extends and clarifies the notion of statistical assurance proposed by O'Hagan. The heavy calculations involved are made possible by the development and use of a meta-model able to replace accurately the complex PBPK model which would othewise be required.
Clinical Decision-Making/methods, Virtual Bioequivalence
Clinical Decision-Making/methods, Virtual Bioequivalence
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