Food and Drug Administration
Anti-Infective Drugs Advisory Committee
February 19, 2002
Slides
Historical Perspective, Selection and Implications of Delta, Renata Albrecht, MD, Division of Special Pathogen and Immunologic Drug Products, FDA ppt htm
Active Control Non-Inferiority Studies: Theory, Assay Sensitivity, Choice of Margin, Robert J Temple, MD, Medical Policy, FDA ppt htm
Statistical Issues in Specification of /\, Daphne Lin, PhD, Erica Brittain, PhD, Dividion of Biometrics III, FDA ppt htm
Targeted Therapy for Fluoroquinolones in Infants and Children, George H McCracken Jr, MD, University of Texas Southwestern Medical Center at Dallas ppt htm
Selection of Delta to Determine Efficacy in Noninferiority Trials of Antibacterial Drugs, David Shlaes, MD, Antimicrobial Working Group of the Pharmaceutical Research and Manufacturers of American (PhRMA) ppt htm
Challenges in Antibacterial Drug Development, Francis P Tally, MD, Cubist Pharmaceuticals, Inc ppt htm
Issues Regarding Choice of the Margin in Non-Inferiority Trials, Thomas R Fleming, PhD, University of Washington ppt htm
Issues in Selection of Deltas in Non-Inferiority Trials: Acute Bacterial Meningitis and Hospital-Acquired Pneumonia, John H Powers, MD, Division of Special Pathogen and Immunologic Drugs Products, FDA ppt htm
Selection of /\ in Clinical Trials of Antimicrobial Therapy - Acute Exacerbation of Chronic Bronchitis, Susan D Thompson, MD ppt htm
Open Public Hearing
Should the Non-Inferiority Margin Vary with the Comparation Rate? An Adaptive Statistical Test, Kem F Phillips PhD, Michael Corrado, MD, Advanced Biologics LLC ppt htm doc