Issues about the rationality of subject selection in chemical generic drug registration application:a discussion
10.13220/j.cnki.jipr2014.04.008
- Author:
Zhen-Yu XU
1
Author Information
1. Center for Drug Evaluation, China Food and Drug Administration
- Publication Type:Journal Article
- Keywords:
Chemical generic drug;
Rationality;
Subject selection
- From:
Journal of International Pharmaceutical Research
2014;41(4):429-431
- CountryChina
- Language:Chinese
-
Abstract:
Some issues about the rationality of subject selection are identified in the registration applications of chemical generic drugs. It should be the sponsor's responsibility to follow the latest information about safety, efficacy and quality control of the proposed drug, and provide a sound basis for subject selection. In this article, issues about the basis of the subject selection of chemical generic drugs are discussed from the aspects of compound, formulation and strength.
