Pharmacometabolomics (PMx) studies use information contained in metabolic profiles (or metabolome) to inform about how a subject will respond to drug treatment. Genome, gut microbiome, sex, nutrition, age, stress, health status, and other factors can impact the metabolic profile of an individual. Some of these factors are known to influence the individual response to pharmaceutical compounds. An individual’s metabolic profile has been referred to as his or her “metabotype.” As such, metabolomic profiles obtained prior to, during, or after drug treatment could provide insights about drug mechanism of action and variation of response to treatment. Furthermore, there are several types of PMx studies that are used to discover and inform patterns associated with varied drug responses (i.e., responders vs. non-responders; slow or fast metabolizers). The PMx efforts could simultaneously provide information related to an individual’s pharmacokinetic response during clinical trials and be used to predict patient response to drugs making pharmacometabolomic clinical research valuable for precision medicine. PMx biomarkers can also be discovered and validated during FDA clinical trials. Using biomarkers during medical development is described in US Law under the 21st Century Cures Act. Information on how to submit biomarkers to the FDA and their context of use is defined herein.

中文翻译：

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药代动力学，生物标志物发现和精密医学中的最新概念。

药代动力学（PMx）研究使用代谢谱（或代谢组）中包含的信息来告知受试者对药物治疗的反应。基因组，肠道微生物组，性别，营养，年龄，压力，健康状况和其他因素会影响个体的代谢状况。已知其中一些因素会影响个体对药物化合物的反应。一个人的新陈代谢特征被称为他或她的“代谢型”。这样，在药物治疗之前，期间或之后获得的代谢组学谱可提供有关药物作用机理和对治疗反应的变化的见解。此外，有几种类型的PMx研究可用于发现和告知与各种药物反应相关的模式（即，反应者与非反应者；慢速或快速代谢者）。PMx的努力可以同时提供与个人在临床试验期间的药代动力学反应有关的信息，并可以用来预测患者对药物的反应，从而使药代动力学的临床研究对精密医学有价值。PMx生物标志物也可以在FDA临床试验中发现并验证。美国法律根据《 21世纪治愈法案》（Stops Cures Act）描述了在医学开发过程中使用生物标记的方法。本文定义了有关如何向FDA提交生物标志物及其使用环境的信息。PMx生物标志物也可以在FDA临床试验中发现并验证。美国法律根据《 21世纪治愈法案》（Stops Cures Act）描述了在医学开发过程中使用生物标记的方法。本文定义了有关如何向FDA提交生物标志物及其使用环境的信息。PMx生物标志物也可以在FDA临床试验中发现并验证。美国法律根据《 21世纪治愈法案》（Stops Cures Act）描述了在医学开发过程中使用生物标记的方法。本文定义了有关如何向FDA提交生物标志物及其使用环境的信息。