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药代动力学/药效学建模:它是什么!

Pharmacokinetic/pharmacodynamic modeling: what it is!

作者信息

Colburn W A

机构信息

Warner-Lambert/Parke-Davis Pharmaceutical Research, Pharmacokinetics/Drug Metabolism Department, Ann Arbor, Michigan 48105.

出版信息

J Pharmacokinet Biopharm. 1987 Oct;15(5):545-55. doi: 10.1007/BF01061762.

Abstract

Although Pharmacokinetic/pharmacodynamic modeling has been around for decades, it is still in its infancy with respect to the future of its current manifestation. Due to the amount of time and other resources that must be committed for successful development and application of these methods, economic incentives must be made available to academic and industrial scientists through the NIH and FDA, respectively. The long-term returns should more than compensate for the investments in the form of scientific understanding of the concentration-effect relationships as well as more efficient and acceptable NDAs. Could this be the answer to the drug lag in the United States and other countries?

摘要

尽管药代动力学/药效学建模已经存在了几十年,但就其当前表现形式的未来而言,它仍处于起步阶段。由于成功开发和应用这些方法必须投入大量时间和其他资源,因此必须分别通过美国国立卫生研究院(NIH)和美国食品药品监督管理局(FDA)向学术和工业科学家提供经济激励。长期回报应以对浓度-效应关系的科学理解以及更高效和可接受的新药申请(NDA)的形式,足以补偿这些投资。这会是美国和其他国家药物滞后问题的答案吗?

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