JSM 2005 - Toronto

Abstract #304608

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 279
Type: Luncheons
Date/Time: Tuesday, August 9, 2005 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304608
Title: Proof of Concept in Exploratory Development
Author(s): Alfred Balch*+
Companies: Novartis Pharmaceuticals
Address: 2 Old Waterloo Rd, Budd Lake, NJ, 07828, United States
Keywords: Flexible Trial Design ; Proof of Concept ; Biomarker
Abstract:

Trials for early decisionmaking include Proof of Mechanism, Proof of Safety, Proof of Bioavailability, and Proof of Efficacy. Flexible trial design using alternative endpoints, including biomarkers and flexible and adaptive analyses, are possible approaches for early decisionmaking and planning development strategies.


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Revised March 2005