JSM 2013 Home
Online Program Home
My Program

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.

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

2013 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

ASA Meetings Department  •  732 North Washington Street, Alexandria, VA 22314  •  (703) 684-1221  •  meetings@amstat.org
Copyright © American Statistical Association.