文档介绍：Bridging Studies - A Genomic Approach
By
Jen-pei Liu, ., Professor 劉仁沛教授
Division of Biometry, Department of Agronomy
National Taiwan University
Division of Biostatistics and Bioinformatics ,
National Health Research Institutes
at
The 34 Training Course on Clinical Trials
Foundation of Medical Professionals Alliance in Taiwan
October 14, 2005
The views expressed in this paper are professional opinions of the presenter and may not necessarily represent the position of the National Taiwan University and National Health Research Institutes, Taiwan.
2017/12/2
1
Acknowledgements and Thanks
Herng-Der Chen, MD, PhD, Center for Drug Evaluation
Mey Wang, PhD, Center for Drug Evaluation
Chin-Fu Hsiao, PhD, National Health Research Institutes
2017/12/2
2
Outline
I. Statistical Interpretation of ICH E5
II. Implementation of Bridging Studies
III. Examples of Bridging Studies
IV. Current Statistical Approaches
V. A Statistical Genomic Approach
VI. Summary
2017/12/2
3
Statistical Interpretation of ICH E5
ICH E5
ICH Harmonised Tripartite Guideline (Feb. 5, 1998)
Ethnic Factors in the Acceptability of Foreign Clinical Data
A US FDA Guidance (Federal Register, June 10, 1998)
2017/12/2
4
Statistical Interpretation of ICH E5
ICH E5
Ethnic Factors in the Acceptability of Foreign Clinical Data
The purpose of this guidance is to facilitate the registration of medicines among ICH regions by mending a framework for evaluating the impact of ethnic factors upon a medicine’s effect, ., its efficacy and safety at a particular dosage and dose regimen.
2017/12/2
5
Statistical Interpretation of ICH E5
Objectives of ICH E5 (Section )
To describe the characteristics of foreign clinical data that will facilitate their extrapolation to different population and support their acceptance as a basis for registration of a medicine in a new region.
To describe regulatory strategies that minimize duplication of clinical data and facilitate acceptance of f