Pharmacogenetic application in drug development and clinical trials.

Pharmacogenetic application in drug development and clinical trials.
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药物遗传学在药物开发和临床试验中的应用。

DOI:
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发表时间:
2001
影响因子:
3.9
通讯作者:
F. A. D. L. Iglesia
F. A. D. L. Iglesia
中科院分区:
医学2区
文献类型:
--
作者:
Michael M. Shi;Michael R. Bleavins;F. A. D. L. Iglesia

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药物遗传学检查个体的遗传特征,以了解对治疗反应的变化。这种方法有可能对新药的开发产生重大影响。药物遗传学原理的应用可以在药物开发过程中节省大量时间和资源。在临床前药物开发中,药物遗传学可以应用于化合物筛选和进入全面临床测试之前识别潜在的副作用。在临床试验中,可以通过分析具有不同药物应答和潜在遗传标记的患者亚群的基因型来对其进行分层。这些数据可以改进临床试验设计,并提供基于患者基因型的优化药物处方的可能性。药物遗传学可以通过识别无应答患者群体来指导治疗干预的发展。高通量基因分型技术的进步通过促进技术障碍和改善药物开发策略、临床试验设计和上市后药物警戒增加了潜力。因此,药物遗传学影响药物开发的各个阶段,并将在不久的将来从根本上改变医学实践。
Pharmacogenetics examines the genetic characteristics of individuals to understand variations in response to therapeutics. This approach has the potential to significantly affect the development of new medicines. The application of pharmacogenetic principles could yield significant time and resource savings within the drug development process. In preclinical drug development, pharmacogenetics could be applied to compound screening and identifying potential side effects before entering full clinical testing. Subpopulations of patients with different drug responses and underlying genetic markers could be stratified in clinical trials by analyzing their genotype. These data can improve clinical trial design and offer the possibility of optimized drug prescription based on patient genotype. Pharmacogenetics can guide the development of therapeutic interventions by identifying nonresponder patient groups. Advances in high-throughput genotyping technologies have added potential by facilitating the technical hurdles and improving drug development strategies, clinical trial design, and postmarket pharmaco-vigilance. Pharmacogenetics, thus, impacts all phases of drug development and will fundamentally change the practice of medicine in the near future.
DOI: 10.1172/jci117838
发表时间: 1995
期刊: The Journal of clinical investigation.
影响因子: --
作者:
Turki,J;Pak,J;Green,SA;Martin,RJ;Liggett,SB
通讯作者: Liggett,SB
药物遗传学:优化治疗效率的实验室工具。
DOI: --
发表时间: 1997
期刊: Clinical chemistry
影响因子: 9.3
作者:
Linder,MW;Prough,RA;ValdesJr,R
通讯作者: ValdesJr,R
DOI: 10.1165/ajrcmb/8.3.334
发表时间: 1993-03-01
影响因子: 6.4
作者:
REIHSAUS, E;INNIS, M;LIGGETT, SB
通讯作者: LIGGETT, SB