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药物代谢动力学:精准药理学的已然到来的未来。

Pharmacometrics: The Already-Present Future of Precision Pharmacology.

机构信息

Laboratory of Immunopathology, Nucleus of Biological Sciences Research, Federal University of Ouro Preto, Ouro Preto, Minas Gerais, Brazil.

出版信息

Ther Innov Regul Sci. 2023 Jan;57(1):57-69. doi: 10.1007/s43441-022-00439-4. Epub 2022 Aug 18.

Abstract

The use of mathematical modeling to represent, analyze, make predictions or providing information on data obtained in drug research and development has made pharmacometrics an area of great prominence and importance. The main purpose of pharmacometrics is to provide information relevant to the search for efficacy and safety improvements in pharmacotherapy. Regulatory agencies have adopted pharmacometrics analysis to justify their regulatory decisions, making those decisions more efficient. Demand for specialists trained in the field is therefore growing. In this review, we describe the meaning, history, and development of pharmacometrics, analyzing the challenges faced in the training of professionals. Examples of applications in current use, perspectives for the future, and the importance of pharmacometrics for the development and growth of precision pharmacology are also presented.

摘要

应用数学模型来表示、分析、预测或提供药物研发中获得的数据信息,使得药物代谢动力学成为一个非常突出和重要的领域。药物代谢动力学的主要目的是提供与寻找药物治疗中疗效和安全性改进相关的信息。监管机构已经采用了药物代谢动力学分析来证明其监管决策的合理性,从而使这些决策更加高效。因此,对该领域专业人才的需求也在不断增长。在这篇综述中,我们描述了药物代谢动力学的含义、历史和发展,分析了在专业人才培养方面所面临的挑战。还介绍了当前应用的实例、未来的展望以及药物代谢动力学对精准药理学的发展和成长的重要性。

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