Personalized medicine in drug development

Abstract

Abstract: Pharmacogenomics has the potential to impact on the drug discovery and development process at many stages.Pharmacogenomic information helps researchers in drug discovery to better identify drug targets and the mechanisms of action of investigational New Chemical Entity (NCEs).Pharmacogenomics-related technology facilitates the removing of unfavorable products at preclinical stages of drug development.It also could guide companies in designing clinical trials that would more definitively confirm drug efficacy, consecutively decreasing the time, costs, and risks of drug development as well.

Key words: pharmacogenomics, drug development, efficacy, safety, clinical trial

CLC Number:

R969

ZHANG Wei, ZHOU Hong-hao. Personalized medicine in drug development[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(10): 1081-1084.

References

[1] Parker B, Wendin C, Whittemore C.Personalized Medicine:The Emerging Pharmacogenomics Revolution.Global Technology Centre &Health Research Institute[J].Price water house Coopers LLP.2005.
[2] Phillips KA, Veenstra DL, Oren E, et al.Potential role of pharmacogenomics in reducing adverse drug reactions:a systematic review[J].JAMA, 2001, 286(18):2270-2279.
[3] 周宏灏. 遗传药理学[M].科学出版社, 2001.
[4] 张伟, 贺毅憬, 周宏灏.遗传药理学的学科发展与未来[J].中国临床药理学与治疗学, 2008, 13(7):961-965.
[5] Marrer E, Dieterle F.Promises of biomarkers in drug development- a reality check[J].Chem Biol Drug Des, 2007, 69(6):381-394.
[6] Drug safety withdrawals in the U.S.not linked to speed of FDA approval.New product approval times do not correlate with degree of safety[R].Tufts CSDD Impact Report. 2007.
[7] Watanabe I, Tomita A, Shimizu M, et al.A study to survey susceptible genetic factors responsible for troglitazoneassociated hepatotoxicity in Japanese patients with type 2 diabetes mellitus[J].Clin Pharmacol Ther, 2003, 73(5): 435-455.
[8] Long RM.Planning for a national effort to enable and accelerate discoveries in pharmacogenetics:the NIH Pharmacogenetics Research Network[J].Clin Pharmacol Ther, 2007, 81(3):450-454.
[9] Giacomini KM, Brett CM, Altman RB, et al.Pharmacogenetics Research Network.The pharmacogenetics research network:from SNP discovery to clinical drug response[J].Clin Pharmacol Ther, 2007, 81(3):328-345.
[10] Little S.The impact of FDA guidance on pharmacogenomic data submissions on drug development[J].Drugs, 2005, 8(8):648-650.
[11] Trepicchio WL, Williams GA, Essayan D, et al.Pharmacogenomic data submissions to the FDA:clinical case studies[J].Pharmacogenomics, 2004, 5(5):519-524.
[12] Mansel RE, Goyal A, Douglas-Jones A, et al.Detection of breast cancer metastasis in sentinel lymph nodes using intra-operative real time GeneSearch BLN Assay in the operating room:results of the Cardiff study[J].Breast Cancer Res Treat, 2009, 115(3):595-600.
[13] Gage BF, Lesko LJ.Pharmacogenetics of warfarin:regulatory, scientific, and clinical issues[J].J Thromb Thrombolysis, 2008, 25(1):45-51.
[14] Innocenti F, Ratain MJ.Pharmacogenetics of irinotecan: clinical perspectives on the utility of genotyping[J].Pharmacogenomics, 2006, 7(8):1211-1221.
[15] Nguyen H, Tran A, Lipkin S, et al.Pharmacogenomics of colorectal cancer prevention and treatment[J].Cancer Invest, 2006, 24(6):630-639.
[16] Maitland ML, Vasisht K, Ratain MJ.TPMT, UGT1A1 and DPYD:genotyping to ensure safer cancer therapy[J] ? Trends Pharmacol Sci, 2006, 27(8):432-437.
[17] EvansWE.Pharmacogenetics of thiopurine S-methyltransferase and thiopurine therapy[J].Ther Drug Monit, 2004, 26(2):186-191.
[18] Stanulla M, Schaeffeler E, Flohr T, et al.Thiopurine methyltransferase (TPMT) genotype and early treatment response to mercaptopurine in childhood acute lymphoblastic leukemia[J].JAMA, 2005, 293(12):1485-1489.
[19] Oh KT, Anis AH, Bae SC.Pharmacoeconomic analysis of thiopurine methyltransferase polymorphism screening by polymerase chain reaction for treatment with azathioprine in Korea[J].Rheumatology(Oxford), 2004, 43(2):156-163.
[20] Marsh S.Pharmacogenetics:global clinical markers[J]. Pharmacogenomics, 2008, 9(4):371-373.
[21] Marsh S, Van Booven DJ, McLeod HL.Global pharmacogenetics:giving the genome to the masses[J].Pharmacogenomics, 2006, 7(4):625-631.