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Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
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Activity Details


411 * Tue, 8/6/2013, 2:00 PM - 3:50 PM CC-513b
Regulatory Challenges in Nonclinical Biostatistics — Topic Contributed Papers
Biopharmaceutical Section , Biometrics Section , Scientific and Public Affairs Advisory Committee
Organizer(s): Priya Kulkarni, Genentech Inc
Chair(s): Anthony Lonardo, ImClone Systems/Lilly
2:05 PM A Predictive Distribution Approach to QbD: Going Beyond the Flaw of Averages to Assess Risk John Peterson, GlaxoSmithKline
2:25 PM Perspectives on Pooling as Described in the ICH Q1E Guidance Stan Altan ; Jyh-Ming Shoung, Janssen R&D ; Yan Shen, Janssen R&D ; Areti Manola, Janssen R&D
2:45 PM The Posterior Probability of Passing a Compendial Standard David LeBlond, CMCStats ; Linas Mockus, Purdue University
3:05 PM Statistical Challenges Arising in Tech Transfers of Lyophilized Biologics and Improvements Made Using a Finite-Sample Chebyshev Inequality and a Lognormal Sum Approximation Lisa Bernstein, Genentech
3:25 PM Discussant: Bert Gunter, Genentech Inc.
3:45 PM Floor Discussion



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