Use of Biomarker in Drug Development-Japanese Perspectives

Predictive Approaches in Drug Discovery and Development: Biomarkers and In Vitro/In Vivo Correlations

Volumn , Issue , 2012, Pages 269-287

  Uyama, Yoshiaki ^a   Ishiguro, Akihiro ^a   Nakamura, Harumasa ^a   Toyoshima, Satoshi ^a  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

Japanese Society of Clinical Pharmacology; JPMA; PGx biomarkers in Japan

Indexed keywords

EID: 84872581669     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118230275.ch11     Document Type: Chapter

References (37)

1. US-FDA. Challenge and Opportunity on the Critical Path to New Medical Products. March 2004.
2. Office of Pharmaceutical Industry Research. Report for the future vision of pharmaceutical industry; Mission and Task toward 2015, 2007.
3. Kola S, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2005;3:711-715.
4. Spear BB, Heath-Chiozzi M, Huff J. Clinical application of pharmacogenetics. Trends Mol Med 2001;7:201-204. 286 USE OF BIOMARKER IN DRUG DEVELOPMENT-JAPANESE PERSPECTIVES
5. ICH E5(R1) guideline. Ethnic factors in the acceptability of foreign clinical data, 1998. Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Efficacy/E5_R1/Step4/E5_R1_Guideline.pdf. Accessed 2011 Dec 26.
6. Uyama Y, Shibata T, Nagai N, et al. Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan. Clin Pharmacol Ther 2005;78:102-113.
7. Pharmaceuticals and Medical Devices Agency, Home page: information for approved drugs. Available at http://www.info.pmda.go.jp/approvalSrch/PharmacySrchInit? Accessed 2011 Dec 26.
8. Ingelman-Sundberg M, Sim SC, Gomez A, et al. Influence of cytochrome P450 polymorphisms on drug therapies: Pharmacogenetic, pharmacoepigenetic and clinical aspects. Pharmacol Ther 2007;116:496-526.
9. Bradford LD. CYP2D6 allele frequency in European Caucasians, Asians, Africans and their descendants. Pharmacogenomics 2002;3:229-243.
10. Nishida Y, Fukuda T, Yamamoto I, et al. CYP2D6 genotypes in a Japanese population: low frequencies of CYP2D6 gene duplication but high frequency of CYP2D6*10. Pharmacogenetics 2000;10:567-570.
11. FDA. Approval letter for change of irinotecan label. Available at http://www.acc essdata.fda.gov/drugsatfda_docs/appletter/2005/020571s024,027,028ltr.pdf. Accessed 2011 Dec 26.
12. Ando Y, Saka H, Ando M, et al. Polymorphisms of UDP-glucuronosyltransferase gene and irinotecan toxicity: a pharmacogenetic analysis. Cancer Res 2000;60:6921-6926.
13. Sai K, Saeki M, Saito Y, et al. UGT1A1 haplotypes associated with reduced glucuronidation and increased serum bilirubin in irinotecan-administered Japanese patients with cancer. Clin Pharmacol Ther 2004;75:501-515.
14. PMDA. The package insert of irinotecan in Japan. Available at http://www.info.pmda. go.jp/go/pack/4240404A1040_1_04/. Accessed 2011 Dec 26.
15. Baselga J, Tripathy D, Mendelsohn J, et al. Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. J Clin Oncol 1996;14:737-744.
16. Lynch TJ, Bell DW, Sordella R, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004;350:2129-2139.
17. Paez JG, Janne PA, Lee JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004;304:1497-1500.
18. Chung WH, Hung SI, Hong HS, et al. A marker for Stevens-Johnson syndrome, Science 2004;428:486.
19. Kaniwa N, et al. HLA-B locus in Japanese patients with anti-epileptics and allopurinol-related Stevens-Johnson syndrome and toxic epidermal necrolysis. Pharmacogenomics 2008;9:1617-1622.
20. FDA. Alert on Dec 12, 2007, Information for Healthcare Professionals (Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, and generics), 2007. Available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor PatientsandProviders/ucm124718.htm. Accessed 2011 Dec 26.
21. Tanaka H, Akaza T, Juji T. Report of the Japanese central bone marrow data center. Clin Transpl 1996;139-144.
22. The Allele frequency Net Database, Allele frequencies in Worldwide Populations. Available at http://www.allele frequencies.net/. Accessed 2011 Dec 26. REFERENCES 287
23. Ozeki T, et al. Genome-wide association study identifies HLA-A*3101 allele as a genetic risk factor for carbamazepine-induced cutaneous adverse drug reactions in Japanese population. Hum Mol Genet 2011;20:1034-1041.
24. Mori M, Yamada R, Kobayashi K, et al. Ethnic differences in allele frequency of autoimmune-disease-associated SNPs. J Hum Genet 2005;50:264-266.
25. The Wellcome Trust Case Control Consortium. Genome-wide association study of 14,000 cases of seven common diseases and 3,000 shared control. Nature 2007; 447:661-678.
26. 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 Sept 28.
27. Pharmaceutical and Medical Devices Agency. Database for package insert information (in Japanese). Available at http://www.info.pmda.go.jp/psearch/html/ menu_tenpu_base.html. Accessed 2011 Dec 26.
28. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Guidance on clinical pharmacokinetic studies of pharmaceuticals. Notification No. 796. 2001 Jun 1.
29. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Guidance on methods of drug interaction study. Notification No. 813. 2001 Jun 4.
30. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Submission of information to regulatory authorities for preparation of guidance on the use of Pharmacogenomics in clinical studies. Notification No. 0318001. 2005 Mar 18.
31. Committee for Genomics in the Japanese Society of Clinical Pharmacology. The report; current situations & future task for utilization of PGx in drug evaluation, 2007.
32. ICH E15 guideline. Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories. Available at http://www. ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E15/Step4/E15 _Guideline.pdf. Accessed 2011 Dec 26.
33. ICH E16 guideline. Biomarkers related to drug or biotechnology product development: context, structure and format of qualification submissions. Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/ E16/Step4/E16_Step_4.pdf. Accessed 2011 Dec 26.
34. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Guidance; points to consider for evaluating genetic test devices based on DNA Chips, Notification No. 0404002. 2008 April 4.
35. Ministry of Health, Labour and Welfare, The final report of the committee for Effective & Safe Drugs Quick to Patients, Ministry of Health, Labour and Welfare, 2007 July 27.
36. Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Guidance; Clinical trials using pharmacogenomics, Notification No. 0930008. 2008 September 30.
37. PMDA. Scientific consultation on pharmacogenomics/biomarkes. Available at http:// www.pmda.go.jp/operations/shonin/info/consult/m03_pharma.html. Accessed 2011 Dec 26.