Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: Report of the first FDA-PWG-PhRMA-DruSafe workshop

Journal of Clinical Pharmacology

Volumn 43, Issue 4, 2003, Pages 342-358

  Lesko, Lawrence J ^a,b   Salerno, Ronald A ^e   Spear, Brian B ^f   Anderson, Donald C ^e   Anderson, Timothy ^e   Brazell, Celia ^g   Collins, Jerry ^c   Dorner, Andrew ^e   Essayan, David ^a   Gomez Mancilla, Baltazar ^e   Hackett, Joseph ^a   Huang, Shiew Mei ^a,b   Ide, Susan ^h   Killinger, Joanne ^e   Leighton, John ^d   Mansfield, Elizabeth ^a   Meyer, Robert ^d   Ryan, Stephen G ⁱ   Schmith, Virginia ^j   Shaw, Peter ^k   Sistare, Frank ^c   Watson, Mark ^l   Worobec, Alexandra ^a   more..

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Off Clin Pharmacol/Biopharmaceut   (United States)

^c Office of Testing and Research   (United States)

^d Office of New Drugs   (United States)

^e PFIZER INC   (United States)

^f ABBOTT LABORATORIES   (United States)

^g GLAXOSMITHKLINE   (United Kingdom)

^h NATIONAL INSTITUTES OF HEALTH   (United States)

ⁱ ASTRAZENECA   (United Kingdom)

^j GLAXOSMITHKLINE   (United States)

^k BRISTOL MYERS SQUIBB   (United States)

^l MERCK RESEARCH LABORATORIES   (United States)

more..

Author keywords

Drug development process; Pharmacogenetics; Pharmacogenomics; Regulatory agencies; Safe harbor

Indexed keywords

FENOLDOPAM; RNA; TRASTUZUMAB;

CONFERENCE PAPER; DECISION MAKING; DNA SEQUENCE; DRUG MANUFACTURE; DRUG RESEARCH; HUMAN; PHARMACOGENETICS; PHARMACOGENOMICS; PROTEIN EXPRESSION;

CLINICAL TRIALS; DECISION MAKING; DRUG DESIGN; GENOMICS; GUIDELINES; HUMANS; PHARMACOGENETICS; PHARMACOLOGY; POLICY MAKING; RESEARCH DESIGN; SAFETY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0037380651     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270003252244     Document Type: Conference Paper

References (21)

1. Lesko LJ, Woodcock J: Pharmacogenomic-guided drug development. Pharmacogenomics J 2002;2(1):22-24.
2. Roses AD: Pharmacogenetics and the practice of medicine, Nature 2000;405:857-865.
3. Evans WE, Relling MV: Pharmacogenomics: translating functional genomics into rational therapeutics. Science 1999;286(5439):487-491.
4. Malmstrom K, Rodriquez-Gomez, Guerra J, Villaran C, Pineiro A, Wei LX, et al: Oral montelukast, inhaled beclomethasone, and placebo for chronic asthma: a randomized, controlled trial. Ann Intern Med 1999;130:487-495.
5. Weinshilboum R: Thiopurine pharmacogenetics: clinical and molecular studies of thiopurine methyltransferase. Drug Metab Dispos 2001;29:601-605.
6. Christiansen M, Larsen LA, Hansen RF, Andersen PS, Vuust J, Kanters J, et al: The genetics of long QT syndrome: mutation detection in 100 families. Am J Human Genet 2001;69(4, Suppl.):604.
7. Liggett SB: The pharmacogenetics of beta 2-adrenergic receptors-relevance to asthma. J Asthma 1999;105:S487-S492.
8. Elston RC, Idury RM, Cardon LR, Lichter JB: The study of candidate genes in drug trials: sample size considerations. Stat Med 1999;18:741-751.
9. Aardema MJ, MacGregor JT: Toxicology and genetic toxicology in the new era of "toxicogenomics": impact of "-omics" technologies. Mutat Res 2002;499:13-25.
10. Fielden MR, Zacharewski TR: Challenges and limitations of gene expression profiling in mechanistic and predictive toxicology. Toxicol Sci 2000;60:6-10.
11. Corton JC, Anderson SP, Stauber AJ, Janszen DB, Kimbell JS, Conolly RB: Entering into the era of toxicogenomics with DNA microarrays. CIIT Activities 1999;19(2):1-9.
12. Waring JF, Jolly RA, Ciurlionis R, Lum PY, Praestgaard JT, Morfitt DC, et al: Clustering of hepatotoxins based on mechanism of toxicity using gene expression profiles. Toxicol Appl Pharmacol 2001;175: 28-42.
13. Pennie WD, Tugwood J, Oliver GJ, Kimber I: The principles and practice of toxicogenomics: applications and opportunities. Toxicol Sci 2002;54:277-283.
14. Spear BB, Heath-Chiozzi ME, Barnes DM, Cheeseman K, Shaw P, Cambell DA, et al: Terminology for sample collection in clinical trials. Pharmacogenomics J 2001;1:101-103.
15. Committee for Proprietary Medicinal Products: Position paper on terminology in pharmacogenetics. London: The European Agency for the Evaluation of Medicinal Products, 2002 [Online]. Available: http://www.emea.eu.int
16. Ioannidis JPA, Ntzani EE, Trikalinos TA, Contopoulos-Ioannidis DG: Replication validity of genetic association studies. Nat Genet 2001;29:306-309.
17. Anderson DC, Gomez-Mancilla B, Spear BB, Barnes DM, Cheeseman K, Shaw PM, et al: Elements of informed consent for pharmacogenetic research: perspective of the pharmacogenetics working group. Pharmacogenomics J 2002;2:284-292.
18. Risch N, Burchard E, Ziv E, Tang H: Categorization of humans in biomedical research: genes, race and disease. Genome Biol 2002;3: 1-12.
19. Aldhous P: Geneticist fears "race neutral" studies will fail ethnic groups. Nature 2002;418:356-357.
20. Mallal S, Nolan D, Witt C, Masel G, Martin A, Moore C, et al: Associations between presence of HLA-B *5701, HLA-DR7 and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir. Lancet 2002;359:727-732.
21. Hetherinton S, Hughes AR, Mosteller M, Shortino D, Baker KL, Spreen W, et al: Genetic variations in HLA-B region and hypersensitivity reactions to abacavir. Lancet 2002;359:1121-1122.