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

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Consideration of Ethnic Factors Intrinsic Factors Body weight (Rosiglitazone) Genotype of drug metabolizing enzymes (Omeprazole and Tolterodine etc.) Genotype of drug transporter (Statins) Metabolized by CYP3A4/5 (Nifedipiene and Simvastatin etc.) Renal function (Fluconazole) Extrinsic Factors (Practical circumstances) Protocol (subjects, operation, meal, etc.) Analytical method and sites Ethnic Factors in PK from Literature Study Drug Information Association www.diahome.org 20
Ethnic Difference in Pharmacokinetics Caffeine (CYP1A2) Pioglitazone (CYP2C8) Tolbutamide (CYP2C9) Omeprazole (CYP2C19) Lansoprazole (CYP2C19) Nortriptyline (CYP2D6) Retrospective Literature Study Nifedipine (CYP3A4/5) Nicotine (CYP2A6) Amlodipine (CYP3A4/5) Rosiglitazone (CYP2C8) Meloxicam (CYP2C9) Tolterodine (CYP2D6) Sorafenib (CYP3A4, UGT1A9) Rosuvastatin (OATP1B1) Simvastatin (CYP3A4/5, OATP1B1) Moxfloxacin (UGT1A1, SULT2A1) Ranitidene (Renal excretion) Fluconazole (Renal excretion) 21
Page 1 and 2: Update on Korea Ch
Page 3 and 4: Trends of MRCTs including Japan (2/
Page 5 and 6: ILD on Temsirolimus Clinical Trial
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: 国際共同試験での日本人
Page 23: Difference among East Asian populat

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

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