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Activity Number: 287 - Characterizing Clinical Dose Response Studies
Type: Topic Contributed
Date/Time: Tuesday, August 1, 2017 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #322948
Title: Characterizing Clinical Dose Response Studies
Author(s): Neal Thomas* and Joseph Wu
Companies: Pfizer and Pfizer, Inc.
Keywords: dose response ; emax ; Bayesian ; small molecule ; biological compounds
Abstract:

Three recent meta-analyses of dose response data will be summarized. One is based on small-molecule data from a single sponsor (Pfizer), one is based on published industry-wide small-molecule data, and one is based on industry-wide biological molecules. The dosing designs that were utilized are described, along with common patterns of dose response. The analyses demonstrate that a single concise parametric Emax model describes most clinical dose response data well. Implications for design and (Bayesian) parametric analyses will be briefly illustrated using the R package clinDR.


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