Abstract #300179

This is the preliminary program for the 2003 Joint Statistical Meetings in San Francisco, California. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 2-5, 2003); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

To View the Program:
You may choose to view all activities of the program or just parts of it at any one time. All activities are arranged by date and time.

The views expressed here are those of the individual authors
and not necessarily those of the ASA or its board, officers, or staff.

Back to main JSM 2003 Program page
JSM 2003 Abstract #300179
Activity Number: 130
Type: Contributed
Date/Time: Monday, August 4, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #300179
Title: Noninferiority of Combination to Its Components for Binary Responses
Author(s): David R. Bristol*+
Companies: Purdue Pharma, L.P.
Address: 6 Cedarbrook Dr., Cranbury, NJ, 08512-3612,
Keywords: noninferiority ; combination ; power ; sample size
Abstract:

When two drugs are simultaneously administered as a combination, the incidence rate of a particular adverse event, or other safety problem, for the combination may exceed that of either component by an unacceptable amount. Thus it is important in the development of the combination to establish that the probability of the occurrence of this specified event for the combination is not too much larger than the maximum of the corresponding probabilities for the components. If this is not the case, then the development of the combination might be discontinued for safety reasons. A hypothesis testing formulation for this problem is presented, with discussion of the power and choice of the appropriate sample size.

  • 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 2003 program

JSM 2003 For information, contact meetings@amstat.org or phone (703) 684-1221. If you have questions about the Continuing Education program, please contact the Education Department.
Revised March 2003