The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Abstract Details
|
Activity Number:
|
626
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Thursday, August 4, 2011 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #302431 |
|
Title:
|
On Statistical Methods for Out-of-Trend Evaluations
|
|
Author(s):
|
Lingmin Zeng*+ and Lanju Zhang and Harry Yang
|
|
Companies:
|
MedImmune, Inc. and MedImmune, Inc. and MedImmune, Inc.
|
|
Address:
|
One MedImmune Way, Gaithersburg, MD, 20878,
|
|
Keywords:
|
out of trend ;
stability ;
monitor
|
|
Abstract:
|
Stability data are often collected to monitor and ensure quality of a pharmaceutical product. One of the important aspects of stability analysis is to identify out-out-trend (OOT) results. It has rapidly gained regulatory interest in the past decade. Although in the literature, several statistical methods have been developed, little has been done to compare the methods. In this talk, we discuss the pros and cons of the currently available OOT methods used in various phases of product development.
|
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 2011 program
|
2011 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.