Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective
Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective
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DOI：
10.1038/nrd1499
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发表时间：
2004-09-01
影响因子：
120.1
通讯作者：
Woodcock, J
中科院分区：
文献类型：
--
作者：
Lesko, LJ;Woodcock, J
药物基因组学和药物遗传学提供了基于 DNA 的测试方法，以改进药物选择、确定最佳剂量、最大限度地提高药物疗效或最大限度地降低毒性风险。基础研究的快速进展已经确定了为通过遗传和/或基因组测试定义的个体和/或患者亚群开发“个性化”治疗的许多机会。然而，将这些测试整合到常规临床实践中仍然是一个重大的多学科挑战，即使对于成熟的生物标志物来说也进展甚微。在这里，我们从监管角度考虑这一挑战，强调 FDA 最近的举措，旨在促进药物遗传学和药物基因组学整合到药物开发和临床实践中。
Pharmacogenomics and pharmacogenetics provide methodologies that can lead to DNA-based tests to improve drug selection, identify optimal dosing, maximize drug efficacy or minimize the risk of toxicity. Rapid advances in basic research have identified many opportunities for the development of 'personalized' treatments for individuals and/or subsets of patients defined by genetic and/or genomic tests. However, the integration of these tests into routine clinical practice remains a major multidisciplinary challenge, and even for well-established biomarkers there has been little progress. Here, we consider this challenge from a regulatory perspective, highlighting recent initiatives from the FDA that aim to facilitate the integration of pharmacogenetics and pharmacogenomics into drug development and clinical practice.