'Primary efficacy endpoint' diaporamas de présentation

Design and Analysis of Clinical Trials

Design and Analysis of Clinical Trials. Instructor: Jen-pei Liu, Ph.D. Department of Statistics National Cheng-Kung University Division of Biostatistics, National Health Research

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BMS Data Update

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Tenofovir Disoproxil Fumarate

Tenofovir Disoproxil Fumarate. NDA 21-356 October 3, 2001 Gilead Sciences, Inc. Foster City, CA. Gilead Consultants. Harry K. Genant, M.D. Professor of Radiology, Orthopedic Surgery and Medicine University of California, San Francisco Robert T. Schooley, M.D.

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BIAS: threats to validity and interpretation

BIAS: threats to validity and interpretation. Bias is the result of systematic error in the design or conduct of a study; a tendency toward erroneous results Systematic error results from flaws in either the (1) method of selection of study participants, or

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BIAS: threats to validity and interpretation

BIAS: threats to validity and interpretation. Bias is the result of systematic error in the design or conduct of a study; a tendency toward erroneous results Systematic error results from flaws in either the (1) method of selection of study participants, or

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NY, 14 December 2007

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Disclosure

Disclosure. Dr. Bhatt has received honoraria from: Astra Zeneca, Bristol-Myers Squibb, Eli Lilly, Millennium, Schering Plough, sanofi aventis, The Medicines Company. This presentation discusses off-label uses of clopidogrel. This study was funded by sanofi aventis and Bristol-Myers Squibb.

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First Example in Respiratory Area

First Example in Respiratory Area. Steroid Nasal Spray Seasonal Allergic Rhinitis, Age ? 12 yr Randomized, Double-Blind, Parallel-Group 5-21 Days of Screening Followed by 2 Weeks of Treatment Placebo, 50mcg, 100mcg, 200mcg, 400mcg, ~ 125 Patients/Treatment.

241 views • 15 slides

Statistical Review

Statistical Review. Boris Zaslavsky, Ph.D., Dr. Sc. FDA/CBER/OBE/DB. Study Design . Cross-over with Two Periods and Two Sequences. Subjects were randomized to either C1INH-nf or Placebo in Period 1. Treatment was then switched in the second period.

164 views • 9 slides