Update on Korea China Japan Tripartite Clinical Trial ... - Apec-ahc.org

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Ethnic Factors -Dose Difference by Region- For 32 % of drugs, US/EU dose was > 2 times higher than Japanese dose Approved drugs in 2001-2007 Arnold FL et al , Clin Pharmaco Therapeut., 87: 714-720, 2010 4
ILD on Temsirolimus Clinical Trial Number of ILD -1 Number of ILD -2 MRCT Phase II (Japan-Korea- China) MRCT Phase III North-South America, EU Japanese Korean Chinese Total IFN 8/20 40.0% 11/20 55.0% 3/30 10.0% 16/29 55.2% 4/32 12.5% 18/28 64.3% ILD 1 :Reported by investigator ILD 2 : Reviewed by ILD advisory board 15/82 18.3% 45/77 58.4% 1/200 0.5% 8/138 5.8% 4/208 1.9% 52/178 29.2% by Japan’s Review Report on Temsirolimus 5
Page 1 and 2: Update on Korea Ch
Page 3: Trends of MRCTs including Japan (2/
Page 7 and 8: Japan’s Activities on Ethnic Fact
Page 9 and 10: Summary of PK data analysis Ethnic
Page 11 and 12: Relative AUC difference Moxifloxaci
Page 13 and 14: APEC LSIF (Life Science Innovation
Page 15 and 16: 1. Overall Recommendations A) MRCTW
Page 17 and 18: Asia’s Role in Global Drug Develo
Page 19 and 20: 国際共同試験での日本人
Page 21 and 22: Ethnic Difference in Pharmacokineti
Page 23: Difference among East Asian populat

Update on Korea China Japan Tripartite Clinical Trial ... - Apec-ahc.org

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