A commentary on drug safety and genomics: Promising new agents may require expansion of guidelines for subject screening in clinical trials

P. Pressman, R. Clemens, Thomas Blackburn, A. Hayes
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引用次数: 1

Abstract

The fatty acid amide hydrolase (FAAH) inhibitors likely represent a novel therapeutic yet complex target with the potential to impact various disease processes that present significant unmet medical needs. Despite a history of significant adverse events and still ill-defined risks associated with FAAH inactivation, potential clinical results of FAAH inhibitors for the management of human diseases suggest strongly that the research not be abandoned. In the present commentary we argue that the way to move forward safely and effectively may lie in universal expansion of clinical trials guidelines and toxicology protocols to include targeted genomic screening of clinical trial subjects. Generalization to the safety testing of many new pharmaceutical agents may be the silver lining of an otherwise dark cloud.
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关于药物安全和基因组学的评论:有前途的新药可能需要扩大临床试验中受试者筛选的指导方针
脂肪酸酰胺水解酶(FAAH)抑制剂可能代表了一种新的治疗性但复杂的靶点,具有影响各种疾病过程的潜力,这些疾病过程存在显著的未满足的医疗需求。尽管存在与FAAH失活相关的重大不良事件历史和仍不明确的风险,但FAAH抑制剂用于人类疾病管理的潜在临床结果强烈表明,该研究不应放弃。在目前的评论中,我们认为安全有效地向前推进的方法可能在于普遍扩展临床试验指南和毒理学方案,以包括临床试验受试者的靶向基因组筛选。对许多新药安全性测试的普遍化可能是乌云中的一线希望。
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