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Activity Number: 17 - Dose Selection and PDUFA VI: Advancing the Model Based Drug Development in Regulatory Environment
Type: Topic Contributed
Date/Time: Sunday, July 29, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #329545 Presentation
Title: Dosing Designs for Bayesian Emax Models
Author(s): Neal Thomas*
Companies: Pfizer
Keywords: dose response; Emax; optimal design

The design and analysis of dose response based on Bayesian Emax models will be described. The focus is creating dosing designs that can serve as initial designs that may then be refined using information specific to the compound. Meta-analyses of a large number of dose response studies will be briefly described to provide an empirical basis for selection of a specific parametric model that adequately describes a high proportion of dose response curves. Analyses of these studies also provide an empirical basis for a prior distribution for the model parameters when combined with information that is available at the time most dose response studies are designed. Software (R package clinDR) will be described that supports implementation of Emax models for clinical data. It includes simulation methods to evaluate Bayesian and non-Bayesian designs and analyses using both repeated-sampling and fully Bayesian approaches. Using the Emax model and the prior distribution, several initial dosing designs are proposed conforming with input constraints such as the maximum number of doses, and the maximum dose permitted relative to the projected ED50.

Authors who are presenting talks have a * after their name.

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