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Activity Number: 607 - Effective Application of Modeling, Simulation and Knowledge Sharing in Drug Development
Type: Topic Contributed
Date/Time: Thursday, August 1, 2019 : 8:30 AM to 10:20 AM
Sponsor: Statistics and Pharmacometrics Interest Group
Abstract #301819 Presentation
Title: Integration of Pharmacometrics and Statistics to Support Study Design Optimization
Author(s): Michael Heathman*
Companies: Metrum Research Group
Keywords: Pharmacometrics; Study Design; Adaptive Study; Bayesian
Abstract:

This talk will focus on the use of pharmacometrics to inform the study design process for a two-stage, adaptive dose-finding, inferentially seamless Phase 2/3 study, designed to streamline drug development. PK/PD models were developed for multiple efficacy and safety endpoints, based upon Phase 1 data and information available from literature. Simulation output from these models was combined, using a clinical utility index, to inform dose selection for the adaptive Phase 2/3 study. The PK/PD models were also used to simulate virtual patient responses for potential study designs in order to optimize adaptive decision criteria. Measures of parameter uncertainty were used to determine the full range of patient responses likely to be observed, ensuring that the study design would operate as intended for a wide range of possible responses.


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