刘仁沛教授Bridging Studies A Genomic Approach.pptVIP

Bridging Studies - A Genomic Approach ;Acknowledgements and Thanks;Outline;Statistical Interpretation of ICH E5;Statistical Interpretation of ICH E5;Statistical Interpretation of ICH E5;Statistical Interpretation of ICH E5 ;Statistical Interpretation of ICH E5 ;Statistical Interpretation of ICH E5 ;Extrapolation and Similarity ;Ethnic Factors ; ;Taiwan’s Strategy to Implement Bridging Study;Stepwise Implementation;Products Requiring No Verification of Ethnic Insensitivity;Products Requiring Verification of Ethnic Insensitivity;Bridging Data Package Summary for the Consideration of Bridging Study;Date;Date;Examples;Examples ;Examples;Examples ;Current Statistical Approaches ;Extrapolation and Similarity Positive treatment effect (better than control) The efficacy or safety of the test drug is better than control in the new region Ho: ?NT - ?NC ? 0 vs. Ha: ?NT - ?NC 0 ; Current Statistical Approaches Positive Rx Effect ;Current Statistical Approaches ;Current Statistical Approaches Equivalence;Current Statistical Approaches;Current Statistical Approaches Non-inferiority;Current Statistical Approaches ;; ;Current Statistical Approaches ;Current Statistical Approaches;Current Statistical Approaches;Current Statistical Approaches ;Current Statistical Approaches ;Current Statistical Approaches ;Current Statistical Approaches ;Current Statistical Approaches ;Current Statistical Approaches ;Current Statistical Approaches ;Current Statistical Approaches ;Current Statistical Approaches ;Current Statistical Approaches ;Current Statistical Approaches ;Targeted Clinical Trials HER2 (the human epidermal growth factor receptor 2) gene in metastatic breast cancer - Herceptin - requirement of screening the patients with over-expressed HER2 level (Slamon, 2001). Estrogen receptor polymorphism - Estrogen Replacement Atherosclerosis trial (ERA, Herrington, et al, 2002): a total of 9 SNPs were identified and interac