JSM 2012 Home

JSM 2012 Online Program

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: 228
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 2:00 PM to 3:50 PM
Sponsor: Section on Bayesian Statistical Science
Abstract - #305262
Title: Implementing Bayesian Methods in Biological Product Development: Regulatory Perspective and Experience
Author(s): Boguang Zhen*+
Companies: FDA/CBER
Address: 1401 Rockville Pike, Rockville, MD, , United States
Keywords: Bayesian ; therapeutic product ; Regulatory perspective

Recently, there are an increasing number of protocols with Bayesian methodology in therapeutic biological product development submitted to CBER/FDA for review. Some of these studies are designed for supporting licensing application and many are at the stage of early phase clinical trial development. The presenter will first summarize the types of Bayesian approaches commonly seen in the submissions, and then share the review experience for such submissions. Issues and challenges in reviewing protocols with Bayesian methodology will be presented and discussed with some hypothetical examples. The talk will also focus on the use of Bayesian approach in confirmatory trials.

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.