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:
|
491
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #305273 |
|
Title:
|
Biomarker Qualification: FDA Experience
|
|
Author(s):
|
Aloka Chakravarty*+
|
|
Companies:
|
FDA/CDER
|
|
Address:
|
7730 Laurel Leaf Drive, Potomac, MD, 20854-1766, United States
|
|
Keywords:
|
biomarker qualification ;
FDA ;
surrogate ;
drug development tool (DDT) ;
regulatory guidance
|
|
Abstract:
|
Biomarker Qualification is a drug development tool (DDT) that guides uniformity of usage for biomarker across all drug development portfolios. Typically, biomarker qualification is undertaken by a consortium rather than individual sponsors so that common knowledge can be shared by all in a particular context of clinical usage.
In this talk, we will discuss definition of the word "qualification" in this paradigm, scope and extent of the qualification, considerations for development of statistical analysis plans and best practices related to design, analysis and interpretation of such. We follow with several regulatory case examples illustrating the concepts
|
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.