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:
|
134
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Monday, July 30, 2012 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #304882 |
|
Title:
|
An Alternative Approach to Immunogenicity Assay Cut-Point Determination
|
|
Author(s):
|
Jianchun Zhang*+ and Lanju Zhang and Harry Yang
|
|
Companies:
|
MedImmune and MedImmune and MedImmune
|
|
Address:
|
868 Quince Orchard Blvd, Gaithersburg, MD, 20878, United States
|
|
Keywords:
|
Immunogenicity ;
Cut Point ;
Non-normality ;
anti-drug antibody
|
|
Abstract:
|
Immunogenicity assays are critical for evaluation of safety profiles of biological drugs. Key to the development and validation of an immunogenicity assay is the determination of a cut point, which serves as the threshold for classifying samples as anti-drug antibody (ADA) positive or negative. In practice, the cut point is statistically derived from data based on drug-naïve samples. When its distribution is not normal, the traditional approach based on normal assumption is no longer appropriate. In this talk, we consider an alternative approach to determining the cut point when the distribution is not normal.
|
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.