Abstract #300722

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 #300722
Activity Number: 454
Type: Contributed
Date/Time: Thursday, August 7, 2003 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #300722
Title: Determining Dissolution Specification Limits with a Bootstrap Tolerance Interval for a Nonlinear Mixed Model
Author(s): Mandy Bergquist*+ and Marie Davidian
Companies: NC State University and North Carolina State University
Address: 3120 Walnut Creek Pkwy., Raleigh, NC, 27606-4617,
Keywords: dissolution ; specification limits ; tolerance interval ; nonlinear mixed model
Abstract:

A new drug sponsor's choice of dissolution specification limits affects the determination of the drug's acceptable shelf life, the sentencing of manufacturing lots, and the cost of manufacturing changes. Common approaches to setting these limits fail to model explicitly sources of variation in the observed dissolution profiles, or they result in specification limits on model parameters rather than on the observed responses, which are of primary interest. This paper proposes a new approach that uses a nonlinear mixed model to account for sources of variation in the dissolution measurements. Appropriate specification limits are determined by the construction of parametric bootstrap tolerance intervals at specified time points. The resulting limits apply to the observed responses rather than the model parameters, eliminating the need to fit a model in order to test newly observed responses against the established limits.

  • 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