The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Online Program Home
Abstract Details
|
Activity Number:
|
256
|
|
Type:
|
Roundtables
|
|
Date/Time:
|
Tuesday, July 31, 2012 : 7:00 AM to 8:15 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #306050 |
|
Title:
|
Statistical Issues in Designing Noninferiority Studies with an Emphasis on Veterinary Medical Issues
|
|
Author(s):
|
Anna Nevius*+
|
|
Companies:
|
FDA/CVM
|
|
Address:
|
7500 Standish Place, Rockville, MD, 20855, United States
|
|
Keywords:
|
Non-inferiority ;
Veterinary Medicine
|
|
Abstract:
|
Non-inferiority 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.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2012 program
|
2012 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.