Criteria for FDA's Acceptance of Results from Pharmacometrics Approaches
An AAPS eLearning Series Webinar
Date: June 2, 2011
Time: 12:45pm - 2:15pm EDT
Speaker: Jogarao Gobburu, PhD, Division of Pharmacometrics, OCP/US FDA
Moderator: Dan Weiner, PhD, Pharsight
Join this webinar for a historical perspective of modeling and simulation (M&S) submissions to FDA, and for insights on strategies to increase the likelihood that M&S results will be acceptable to FDA for review. Questions addressed include: What should be addressed in the submission? For which approaches has FDA received training, and what if a sponsor wants to perform M&S based on some other approach? How are reviewers assigned to specific submissions, and is there a checklist of things they look for? The webinar will include an interactive question and answer session.
[이 게시물은 티앤제이테크님에 의해 2011-06-14 14:15:49 자료실에서 이동 됨]