This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 365
Type: Roundtables
Date/Time: Tuesday, August 3, 2010 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307778
Title: Statistical Issues in Designing Active Control Studies with an Emphasis on Veterinary Medical Issues
Author(s): Anna B. Nevius*+
Companies: FDA/CVM
Address: 7500 Standish Place, Rockville, MD, 20855,
Keywords: Active control studies ; Veterinary Medicine
Abstract:

Active Control Studies represent an important class of designs for studying efficacy in the drug approval process. Many of the design issues are the same for human and animal medicine. However, veterinary medicine presents unique challenges including the choice of a control group, sample size, and choice of primary variable endpoint. The implications of related guidance from FDA and other institutions will be discussed.


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