Effective global drug development strategy for obtaining regulatory approval in japan in the context of ethnicity-related drug response factors

Clinical Pharmacology and Therapeutics

Volumn 87, Issue 3, 2010, Pages 362-366

  Ichimaru, K ^a   Toyoshima, S ^a   Uyama, Y ^a  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

GEFITINIB; INSULIN GLULISINE; LEFLUNOMIDE; LOSARTAN POTASSIUM; PLACEBO; ROSUVASTATIN; TOLTERODINE; TRASTUZUMAB;

AREA UNDER THE CURVE; BREAST CANCER; CANCER SURVIVAL; CAUCASIAN; CLINICAL TRIAL; DIABETIC NEPHROPATHY; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; DRUG RESPONSE; DRUG SAFETY; ETHNIC DIFFERENCE; ETHNICITY; GENETIC RECOMBINATION; HUMAN; INTERSTITIAL LUNG DISEASE; JAPAN; JAPANESE; MEDICAL SOCIETY; NON INSULIN DEPENDENT DIABETES MELLITUS; OVERACTIVE BLADDER; PRIORITY JOURNAL; SHORT SURVEY;

BIOMARKERS, PHARMACOLOGICAL; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG DISCOVERY; ETHNIC GROUPS; HUMANS; INTERNATIONALITY; JAPAN; PHARMACEUTICAL PREPARATIONS;

EID: 77149143531     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.285     Document Type: Short Survey

References (25)

1. Thiers, F.A., Sinskey, A.J., & Berndt, E.R. Trends in the globalization of Clinical trials. Nat. Rev. Drug Discov. 7, 13-14 (2008).
2. Mori, K., Toyoshima, S. Recent approaches by the PMDa to promoting new drug development: changes in the status of the PMDa in relation to new drug development over the last fve years. Drug Inf. J. 43, 47-55 (2009).
3. Fukuhara, h. Time lags between the world's frst launch of new drugs and launch in other countries-for improving the access to new drugs in Japan. (No.31, Research Paper Series) (Office of Pharmaceutical Industry Research, 2006).
4. Uyama, Y., Shibata, T., Nagai, N., Hanaoka, H., Toyoshima, S. & Mori, K. Successful bridging strategy based on Ich E5 guideline for drugs approved in Japan. Clin. Pharmacol. Ther. 78, 102-113 (2005).
5. Reference data. "Efective & Safe drugs Quick to Patients" committee (Ministry of health Labour & Welfare, Tokyo, Japan, 2007).
6. Bjornsson, T.D. et al. A review and assessment of potential sources of ethnic diferences in drug responsiveness. J. Clin. Pharmacol. 43, 943-967 (2003).
7. Azuma, A. & Kudoh, S. High prevalence of drug-induced pneumonia in Japan. Jpn. Med. Assoc. J. 50, 405-411 (2007).
8. Pharmaceuticals and Medical Devices agency. Lefunomide Review Report (2003). http://www.info.pmda.go.jp/shinyaku/ g030403/78006900-21500aMY00076- Q102-1.pdf
9. Sekine, I., Yamamoto, N., Nishio, K. & Saijo, N. Emerging ethnic diferences in lung cancer therapy. Br. J. Cancer 99, 1757-1762 (2008).
10. Pharmaceuticals and Medical Devices agency. Geftinib Review Report (2002).
11. Pharmaceuticals and Medical Devices agency. Rosuvastatin calcium Review Report (2004).http://www.info.pmda.go.jp/shinyaku/ g050104/67022700- 21700aMY00008-a102-1.pdf
12. Pharmaceuticals and Medical Devices agency. Losartan Review Report (2006).http://www.info.pmda.go.jp/shinyaku/ g060410/63015300-21000aMZ00678-Q101- 1.pdf
13. Kurokawa, K., Chan, J.C., cooper, M.E., Keane, W.F., Shahinfar, S. & Zhang, Z. Renin angiotensin aldosterone system blockade and renal disease in patients with type 2 diabetes: a subanalysis of Japanese patients from the RENaaL study. Clin. Exp. Nephrol. 10, 193-200 (2006).
14. Chan, J.c. et al. Renin angiotensin aldosterone system blockade and renal disease in patients with type 2 diabetes. an asian perspective from the RENaaL study. Diabetes. Care 27, 874-879 (2004).
15. Pharmaceuticals and Medical Devices agency. Tolterodine Review Report, (2006). http://www.info.pmda.go.jp/shinyaku/ g060403/40007900-21800aMY10088- Q101-1.pdf http://www. info.pmda.go.jp/shinyaku/g060403/40007900-21800aMY10088- Q102-1.pdf http://www.info.pmda.go.jp/shinyaku/ g060403/40007900-21800aMY10088- Q103-1.pdf
16. Pharmaceuticals and Medical Devices agency. Trastuzumab Review Report (2008).http://www.info.pmda.go.jp/shinyaku/ r07/0104/45004500-21300aMY00128- a100-2.pdf
17. Piccart-Gebhart, M.J. et al. Trastuzumab after adjuvant chemotherapy in hER2-positive breast cancer. N. Engl. J. Med. 353, 1659-1672 (2005).
18. Smith, I. et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in hER2-positive breast cancer: a randomised controlled trial. Lancet. 369, 29-36 (2007).
19. Pharmaceuticals and Medical Devices agency. Insulin Glulisine (Genetical Recombination) Review Report (2009).http://www.info.pmda.go.jp/shinyaku/ g090409/78006900-22100aMX00656-a100-1.pdf
20. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of health, Labour and Welfare. Basic Principles on Global Clinical Trials. Notification no.0928010 (2007). http://www.pmda.go.jp/english/service/ pdf/notifications/0928010-e.pdf
21. Kawai, N., chuang-Stein, C., Komiyama, O. & Li, Y. an approach to rationalize partitioning sample size into individual regions in a multiregional trial. Drug Inf. J. 42, 139-147 (2008)
22. Quan, H., Zhao, P.L., Zhang, J., Roessner, M. & aizawa, K. Sample size considerations for Japanese patients in a multi-regional trial based on MhLW guidance. Pharm. Stat. (2009); e-pub ahead of print 4 June 2009.
23. Pharmaceuticals and Medical Devices agency. Ich E5 Guideline: Ethnic Factors in the acceptability of Foreign Clinical Data (1998). http://www.pmda.go.jp/ ich/e/e5r1-98-8-11e.pdf
24. The International hapMap consortium. a haplotype map of the human genome. Nature 437, 1299-1320 (2005).
25. Myrand, S.P. et al. Pharmacokinetics/genotype Associations for major cytochrome P450 enzymes in native and frst-and third-generation Japanese populations: comparison with Korean, chinese, and caucasian populations. Clin. Pharmacol. Ther. 84, 347-361 (2008).