Adaptive Dose Ranging Studies: An Update from the PhRMA Working Group
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*Jose Pinheiro, Novartis Pharmaceuticals 


As part of its Pharmaceutical Innovation initiative, PhRMA formed a working group on adaptive dose ranging studies (ADRS) to evaluate and make recommendations on the use of this class of designs to improve dose selection in drug development. Preliminary conclusions and recommendations followed and extensive simulation study comparing adaptive and non-adaptive dose finding methods. This talk will present an overview of the second round of evaluations produced by the WG, focusing on additional adaptive dose-ranging methods, the use of exposure-response models in dose finding, and the impact of dose selection in Phase II on the probability of success of Phase III programs. Updated conclusions and recommendations will be presented and discussed.