Statistical Issues and Challenges in Combination Vaccines Ivan S. F. Chan, Ph.D. Merck Research Laboratories Sang Ahnn, Ph.D. CBER, FDA 2005 FDA/Industry.
Evaluation of a potential mutagenic MOA based on analysis of the weight of evidence and using the modified Hill criteria Martha M. Moore, Ph.D. Director,
Institutional Review Board for Human Research (IRB) Human Subject Protections Susan Sonne, PharmD, BCPP Chair, MUSC IRB II.