Pharmacogenetics in drug development: Regulatory and clinical considerations

Drug Development Research

Volumn 62, Issue 2, 2004, Pages 102-111

  Hall, Susan T ^a   Abbott, Neil ^b   Schmith, Ginny ^a   Brazell, Celia ^b  

^a GLAXOSMITHKLINE   (United States)

^b GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Clinical; Drug development; Pharmacogenetics; Regulatory

Indexed keywords

ACYLTRANSFERASE; ATAZANAVIR; ATOMOXETINE; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; THIOPURINE METHYLTRANSFERASE; TRASTUZUMAB;

DNA SEQUENCE; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG LABELING; DRUG METABOLISM; DRUG RESEARCH; DRUG SAFETY; EUROPE; FOOD AND DRUG ADMINISTRATION; GENOTYPE; GOOD CLINICAL PRACTICE; GOOD LABORATORY PRACTICE; HEALTH CARE DELIVERY; HEALTH CARE POLICY; HUMAN; INFORMED CONSENT; JAPAN; LIVER TOXICITY; PHARMACOGENETICS; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; UNITED STATES;

EID: 9644281174     PISSN: 02724391     EISSN: None     Source Type: Journal    
DOI: 10.1002/ddr.10372     Document Type: Review

References (39)

1. Anderson DC, Gomez-Mancilla B, Spear BB, Barnes DM, Cheeseman K, Shaw PM, Friedman J, McCarthy A, Brazell C, Ray SC, McHale D, Hashimoto L, Sandbrink, R, Watson ML, Salerno RA, Cohen N, Lister CE. 2002. Elements of informed consent for pharmacogenetic research; perspectives of the pharmacogenetics working group. Pharmacogenomics J 2:284-292.
2. CPMP. 1997. http://www.emea.eu.int/pdfs/human/ewp/056095en.pdf. Note for guidance on the investigation of drug interactions.
3. EMEA. 2000. EMEA/CPMP/1483/00. Seminar on the "Use of pharmacogenetics in the drug development process."
4. EMEA. 2003. CPMP/4445/03. "Concept paper on pharmacogenetics: briefing meetings."
5. EMEA. 2004. EMEA/3842/04/Final. Undestanding the terminology used in pharmocogenetics.
6. EMEA/CPMP. 2001. EMEA/CPMP/3070/01. Position paper on "Terminology in pharmacogenetics".
7. Evans WE, Relling MV. 1999. Pharmacogenomics: Translating functional genomics into rational therapeutics. Science 286:487-491.
8. FDA 1999a. www.fda.gov/cder/guidance/1852fnl.pdf. Guidance for Industry: Population Pharmacokinetics.
9. FDA. 1999b. www.fda.gov/cder/guidance/2635fnl.pdf. In vivo drug metabolism/drug interaction studies: study design, data analysis and recommendations for dosing and labeling.
10. FDA. 2003a. www.fda.gov/bbs/topics/news/2003/beyond2002/report.html. Improving innovation in medical technology: Beyond 2002.
11. FDA. 2003b. www.fda.gov/cder/guidance/3625fnl.pdf. Pharmacokinetics in patients with impaired hepatic function: study design, data analysis and impact on dosing and labeling.
12. FDA. 2003c. www.fda.gov/cder/guidance/5341fhl.pdf. Exposure-response relationships: Study design, data analysis, and regulatory applications.
13. FDA. 2003d. www.fda.gov/cder/guidance/5900dft.pdf. Guidance for industry: Pharmacogenomic Data Submissions.
14. FDA. 2003e. www.fda.gov/cdrh/oivd/guidance/1210.pdf. Draft Guidance for Industry and FDA reviewers; Multiplex tests for heritable DNA markers, mutations, and expression patterns.
15. FDA. 2003f. http://www.fda.gov/oc/mcclellan/strategic.html. Protecting and advancing America's health: A strategic action plan for the 21st century.
16. FDA. 2003g. http://www.fda.gov/ohrms/dockets/ac/03/minutes/3971M1.pdf. Summary minutes of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee.
17. FDA. 2004. www.fda.gov/oc/initiatives/criticalpath/whitepaper.html. Innovation Stagnation: Challenge and opportunity on the Critical Path to new medical technologies.
18. Hetherington S, Hughes AR, Mosteller M, Shortino D, Baker KL, Spreen W, Lai E, Davies K, Handley A, Dow DJ, Fling ME, Stocum M, Bowman C, Thurmond LM, Roses AD. 2002. Genetic variations in HLA-B region and hypersensitivity reactions to abacavir. Lancet; 359:1121-1122.
19. ICH E4. 1994. http://www.ich.org/MediaServer.jser?@_ID=480&@_MODE= GLB. Dose response information to support drug registration.
20. ICH E5. 1998. http://www.ich.org/MediaServer.jser?@_ID=481& @_MODE=GLB Ethnic factors in the acceptability of foreign clinical data.
21. Koppal T. 2002. Inside the FDA: Turning dossiers into drugs with CDER's Dr. Janet Woodcock. Drug Disc Dev 5:31-38.
22. Lesko LJ, Woodcock J. 2002. Pharmacogenomic-guided drug development: regulatory perspective. Pharmacogenomics J 2: 20-24.
23. Lesko LJ, Salerno RA, Spear BB, Anderson DC, Anderson T, Brazell C, Collins, J, Dorner A, Essayan D, Gomez-Mancilla B, Hackett J, Huang SM, Ide S, Killinger J, Leighton J, Mansfield E, Meyer R, Ryan SG, Schmith, V, Shaw P, Sistare F, Watson M, Worobec A. 2003. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making. J Clin Pharmacol 43:342-358.
24. Mallal S, Nolan D, Witt C, Masel G, Martin AM, Moore C, Sayer D, Castley A, Mamotte C, Maxwell D, James I, Christiansen FT. 2002. Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir. Lancet 359:727-732.
25. Mansfield E. 2003. Genetic testing and personalized medicine: an FDA view. Preclinica 1:155-158.
26. MHLW. 2000. www.jpma.or.jp Manager of Evaluation and Licensing Division, Pharmaceutical and Medical Safety Bureau: Concerning the guidance for clinical pharmacokinetic studies.
27. MHLW. 2001. ELD Notification No. 796 Guidance on clinical pharmacokinetics/pharmacodynamics.
28. MHLW. 2001. ELD Notification No. 813. Guidance on drug-drug interaction study.
29. MHLW. 2004. http://search.e-gov.go.jp/servlet/Public?CLASSNAME= Pcm1010&BID=495040017. "Submission of information to administrative bodies regarding the preparation of guidelines on the usage of pharmacogenomics in clinical studies on drugs".
30. Pharmacogenetics Working Group. 2001. Terminology for sample collection in clinical genetic studies. Pharmacogenomics J 1:101-103.
31. Roses AD. 2000a. Idiosyncratic reactions to drugs: Can medicine response profiles provide a diagnostic drug surveillance system? Clin Chem Lab Med 38:815-818.
32. Roses AD. 2000b. Pharmacogenetics and the practice of medicine. Nature 405:857-865.
33. Roses AD. 2001. How will pharmacogenetics impact the future of research and development? Drug Discov Today 6:59-60.
34. Roses AD. 2002. SNPs: where's the beef? Pharmacogenomics J 2:277-283.
35. Salerno RA, Lesko LJ. 2004. Phamacogenomics in drug development and regulatory decision-making: the Genomic Data Submission (GDS) proposal. Pharmacogenomics 5:1-6.
36. Shah RR. 2003. Regulatory aspects of pharmacogenetics and pharmacogenomics. Bundesgesundheitsbl-Gesundheitsforsch-Gesundheitsschutz 46:855-867.
37. Spear BS, Heath-Chiozzi M, Huff J. 2001. Clinical application of pharmacogenetics. Trends Mol Med 7:201-204.
38. Wormhoudt LW, Commandeur JNM, Vermeulen NPE. 1999. Genetic polymorphisms of human N-acetyltransferase, cytochrome P450, glutathione-S-transferase, and epoxide hydrolase enzymes: relevance to xenobiotic metabolism and toxicity. Crit Rev Toxicol 29:59-124.
39. Xu C-F, Lewis KF, Yeo AJ, McCarthy LC, Maguire MF, Caine C, Anwar Z, Danoff TM, Roses AD, Purvis IJ. 2004. Identification of a pharmacogenetic effect by linkage disequilibrium mapping. Pharmacogenomics J (in press).