药代动力学在药物申报中的应用

Application of pharmacokinetics in regulatory submission of products

本文根据国际制药的前沿发展状况,探讨药代动力学在药物申报中的广泛应用。在国际上,不论是新药还是改进药型或是非专利仿制药,都需要药代动力学的支持。从其安全性和有效性的角度,药物审批监管机构需要尽可能完整地了解药物在体内的过程,把握药物的性能,为审批和监管提供科学依据。而药代动力学可依据生物利用度的基本原理,给研究者和公众提供详尽的药物在体内代谢过程的图像。因此,围绕药物申报的药代动力学研究及其软件应用,也得到了广泛地发展。

This article, based upon the frontier development of interna-tional pharmaceutical industry, explores the general applications of phar-macokinetics on regulatory submission of drug development.At present, no matter the product is a new drug or a new formulation or a generic product, the support from pharmacokinetics study is needed.Out of the safety and efficacy, drug regulatory authority wishes to learn as complete as possible the entire process of study drug in the body, so as to under-stand the nature of the drug, and to define the scientific rationale to approve and monitor the drug.It is the application of pharmacokinetics that employs the principle of bioavailability to provide a detailed picture of the process of the drug in human body for the researchers and public.The application studies and software of pharmacokinetics surrounding the regulatory submission are now undergoing a rapid development.