生物标志物在药物研发和监管中的作用：个性化医学临床实施的范例。
Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine.
机构信息
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
出版信息
Biomark Med. 2011 Dec;5(6):705-13. doi: 10.2217/bmm.11.90.
The post-genomic era has been hallmarked by significant enthusiasm for therapeutic individualization through the use of pharmacogenomic and other biomarkers. This enthusiasm has been dampened by limited examples of widespread clinical adoption. The current clinical implementation paradigm may not be adequate to facilitate uptake of pharmacogenetics for a variety of reasons. This paper discusses certain limitations of the classical clinical implementation paradigm and describes the drug development paradigm as an additional, powerful mechanism to facilitate clinical implementation of individualized therapeutics.
后基因组时代的一个显著特点是，人们热衷于通过应用药物基因组学和其他生物标志物来实现治疗个体化。然而，这种热情受到了广泛临床应用的有限例子的抑制。由于各种原因，当前的临床实施模式可能不足以促进药物遗传学的应用。本文讨论了经典临床实施模式的某些局限性，并描述了药物开发模式作为促进个体化治疗临床实施的另一种强大机制。
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