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Drugs

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Clinical Trial Design for Community-Acquired Pneumonia; Public Workshop, January 17-18, 2008, Presentations

FDA Presentations

Workshop Welcome (PDF - 47KB) - David Gilbert, MD
Adult CAP of modest severity not requiring hospitalization (PDF - 140KB) - David Gilbert, MD
Clinical endpoints of therapy for mild-moderate CAP (PDF - 3MB) - David Gilbert, MD
Overview of recent CAP trials: Non-inferiority trial design and endpoints (PDF - 228KB) - Karen Higgins, Sc.D.
Pre-marketing assessment of drug safety in CAP (PDF - 62KB) - Tatiana Oussova, MD, MPH
Treatment effect of antibacterial drugs in community-acquired pheumonia: A historical and regulatory perspective (PDF - 672KB) - Mary Singer, MD, PhD
FDA experience and perspective on non-inferiority trials (PDF - 241KB) - Robert Temple, MD

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