Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
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| 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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