PMID: 9179979May 30, 1997Paper

A population approach to initial dose selection

Statistics in Medicine
J Wakefield, S Walker

Abstract

Before a drug can be marketed, an initial dose must be established. Sheiner et al. argue that a population approach leads to the most informed and rational decision making. We discuss the choice of an initial dose from both a predictive and estimative viewpoint. Our criteria are based upon evaluating the probabilities that a patient from the specified population obtains a response that is at least of a specified size. We demonstrate the approach using a simulation study and compare estimation of population parameters and initial dose using Bayesian and likelihood-based methods.

Citations

Sep 2, 2006·Statistics in Medicine·Deborah Ashby
Apr 9, 1998·Statistical Methods in Medical Research·A Racine-Poon, J Wakefield

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