JSM 2004 - Toronto

Abstract #301336

This is the preliminary program for the 2004 Joint Statistical Meetings in Toronto, Canada. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2004); 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 2004 Program page
Activity Number: 220
Type: Contributed
Date/Time: Tuesday, August 10, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301336
Title: Statistical Methods for Pilot Bioequivalence Trials
Author(s): Guohua Pan*+ and Yibin Wang
Companies: Johnson & Johnson Pharmaceutical R&D, LLC and Novartis Pharmaceuticals
Address: 1125 Trenton-Harbourton Rd., Titusville, NJ, 08560,
Keywords: pilot trial ; bioequivalence ; two-stage process ; sample size determination ; power function ; cross-over design
Abstract:

In clinical development of a bioequivalent (BE) drug product, a two-step strategy is sometimes adopted. At the first step, a pilot BE trial is conducted to evaluate the acceptability of the test drug product as a candidate for further evaluation in a subsequent pivotal BE trial. At the second step, a full-scale pivotal BE trial is conducted to formally establish bioequivalence. The objective and criterion of a pilot BE trial are different from those of a pivotal BE trial. However, in practice, a pilot BE trial is often designed and analyzed based on the criterion and methods for a pivotal BE trial. This talk proposes and discusses some practical statistical methods that can be easily applied to address the specific objective of a pilot BE trial within the two-step framework.

  • 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 2004 program

JSM 2004 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.
Revised March 2004