Application of pharmacokinetics in regulatory submission of products
10.13699/j.cnki.1001-6821.2015.09.025
- VernacularTitle:药代动力学在药物申报中的应用
- Author:
Hua-Qiong SHEN
1
;
Ya-Jiang HE
Author Information
1. 恒瑞医药公司 创新药临床医学部门
- Keywords:
pharmacokinetics;
clinical trial;
regulatory submission;
new drug development and generic product;
pharmacokinetics software
- From:
The Chinese Journal of Clinical Pharmacology
2015;(9):758-761
- CountryChina
- Language:Chinese
-
Abstract:
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.
