Case Studies of the Use of Meta-Analyses of Drug Safety Questions in the Regulatory Setting - Jesse A. Berlin (Johnson & Johnson Pharmaceutical Research and Development

Role of Integrated Analysis in Regulatory Applications - H.M. James Hung, Division of Biometrics I, OB/OTS/CDER, FDA

Integrated Dose-Exposure-Response Modeling and Use in Clinical Trial Simulation - Jerry Nedelman, Novartis Pharmaceuticals

Meta-analysis in Randomized Clinical Trials with Low Event Rates - Jonathan J. Shuster, Dept. of Epidemiology & Health Policy Research, College of Medicine, Univ. of Florida