Considerations of clinical trials for lipid-altering drugs registration
10.3969/j.issn.1001-6821.2009.06.020
- VernacularTitle:调脂药物注册临床试验的考虑
- Author:
Cai-Lian KANG
1
Author Information
1. 国家食品药品监督管理局药品审评中心
- Keywords:
lipid-altering drugs;
registration;
clinical trials
- From:
The Chinese Journal of Clinical Pharmacology
2009;25(6):557-560
- CountryChina
- Language:Chinese
-
Abstract:
The aim of this article is to introduce the considerations of clinical trials for lipid-altering drugs registration. The efficacy is shown by three aspects: altering the lipid parameters, vascular protection, mortality and main cardiovascular events decrease. The safety characteristics are focused on liver, muscle and long term cardiovascular events rate. The article is also referring the especial considerations for clinical trials conducted in children.
