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Role of the clinical laboratory in personalized medicine: challenges and opportunities

机译:临床实验室在个性化医学中的作用:挑战与机遇

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The recent US FDA decision to include information about pharmacogenomic (PGx) testing on the warfarin package insert accelerates the nascent interest in this area among clinical labo-ratorians. PGx testing for genetic variability that can affect treatment response is a key player in implementing personalized medicine. In recent years, many have speculated how and when the choice and dosage of drugs for patient care would be affected, or even driven, by testing for genetic variants [1,2]. Interest in this area has grown rapidly, spurred on by studies showing association, if not causality, between certain mutations and/or single nucleotide polymorphisms (SNPs) and adverse drug reactions or likelihood of efficacy. Clinical laboratories, especially in academic medical centers, are uniquely suited for a role in identifying and implementing PGx assays in collaboration with pharmacists, human geneticists, clinical care providers and researchers. It is in these multidisciplinary settings that the greatest strides in PGx are likely to be made.
机译:美国食品和药物管理局最近决定在华法令包装说明书中包含有关药物基因组学(PGx)测试的信息,这加速了临床实验室医师对该领域的新生兴趣。 PGx可能影响治疗反应的遗传变异性测试是实施个性化药物的关键因素。近年来,许多人猜测通过测试基因变异会如何以及何时影响,甚至驱动用于患者护理的药物的选择和剂量[1,2]。由于研究显示某些突变和/或单核苷酸多态性(SNP)与药物不良反应或疗效的可能性之间存在因果关系,因此对该领域的兴趣迅速增长。临床实验室,特别是学术医学中心的实验室,非常适合与药剂师,人类遗传学家,临床护理提供者和研究人员合作,鉴定和实施PGx分析。正是在这些多学科的背景下,PGx才可能取得最大的进步。

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