Online Program Home
  My Program

All Times EDT

Abstract Details

Activity Number: 182 - Modern Applications of Statistical Methods in Marketing
Type: Contributed
Date/Time: Tuesday, August 4, 2020 : 10:00 AM to 2:00 PM
Sponsor: Section on Statistics in Marketing
Abstract #311030
Title: Immunogenicity Assessment and Extrapolation in BDRS
Author(s): Xin Cao*
Companies: Merck & Co Inc
Keywords: Bridging data report; Immunogenicity; Legacy data
Abstract:

International Conference on Harmonization Guidance on Ethnic Factors (ICH E5) provides guidance with respect to regulatory and development strategies that will permit adequate evaluation of the influence of ethnic factors while minimizing duplication of clinical studies and supplying medicinal products expeditiously to patients. It should not be necessary to repeat the entire clinical drug development program in the new region and is intended to recommend strategies for evaluating foreign clinical data as fully or partially supportive of approval of an application in a new region. Instead, some Asian countries routinely require a comparison of local data (data from the country where the marketing application is being submitted) to the global data referred as the BDR (Bridging Data Report). The BDR (Bridging Data Report) generally includes a summary of data from the specific country in comparison with the global data. Based on the evaluation of the consistency of the local versus global data, a rationale for extrapolation of the foreign (non-Asian) efficacy and safety data to these countries is made to support registration.


Authors who are presenting talks have a * after their name.

Back to the full JSM 2020 program