Slide 1Statistical Methods for Assessment of Individual/Population Bioequivalence Shein-Chung Chow, Ph.D. Biostatistics and Clinical Data Management Millennium Pharmaceuticals,…
Slide 1Introduction to Bayesian inference and computation for social science data analysis Nicky Best Imperial College, London www.bias-project.org.uk Slide 2 Outline Overview…
1. FDA DRAFT GUIDANCE March 2001 Professor Peivand Pirouzi Food and Drug Administration 2001Ref: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074850.htm1…
1. A ssociation forC ANCERIM MUNO T HERAPY(CIMT)29. DEUTSCHERKREBSKONGRESS Berlin 24. – 27. Februar 2010 Individualisierte Immunintervention in der Tumormedizin www.cimt.eu…
1. FDA DRAFT GUIDANCE FOR INDUSTRY REVISED Stuart E Coleman Promotional Review and Regulatory March 30th, 2015 1 2. Brief Summary and Adequate Directions for Use: Disclosing…
1. 1 Adaptive Design in Clinical Trials Joseph Levy, PhD Teva Pharmaceutical Industries MedicReS 2013 Istanbul 2. 2 Outline What are adaptive designs? Review of possible…
Slide 1 1 FDA DRAFT GUIDANCE ON CLINICAL TRIAL DATA MONTORING COMMITTEES Susan S. Ellenberg, Ph.D. Office of Biostatistics and Epidemiology Center for Biologics Evaluation…
Slide 1 Adaptive Designs for Clinical Trials Frank Bretz Novartis 24 April 2013, Tel Aviv Slide 2 What are Adaptive Designs? 2 Slide 3 Three definitions of adaptive designs…
Slide 1 Exploration of Endpoints for Pivotal Clinical Trials to Treat AUD Raye Z. Litten, Ph.D. Daniel Falk, Ph.D. (Discussant) Division of Treatment and Recovery Research…