Similarities and differences of new drug phase Ⅳ clinical trials and post -marketing drug evaluation as well as existing problems
- VernacularTitle:新药Ⅳ期临床试验与药品上市后再评价的异同点以及存在的问题
- Author:
Ai-Lian SHAN
1
;
Yu-Feng JIANG
Author Information
1. 北京大学 第一医院 临床药理研究所
- Keywords:
post-marketing drug evaluation;
new drug phase Ⅳclini-cal trial;
clinically verified trials having inclination to pharmaceutical promotion;
regulations for new drug approval;
regulations for registration and management of new drug
- From:
The Chinese Journal of Clinical Pharmacology
2014;(5):387-390,396
- CountryChina
- Language:Chinese
-
Abstract:
With the retrospection of the background information of new drug phase Ⅳ clinical trials and post -marketing drug evaluation , this paper compared their similarities and differences and explored the exist-ing problems.Meanwhile , it illustrated the characteristics of clinically verified trials having inclination to pharmaceutical promotion , anticipating helping clinicians and clinical pharmacists clarify the purpose and range of clinical trials, and providing data for clinical rational drug use by dis-tinguishing among new drug phase IV clinical trial , post-marketing drug evaluation and clinical trials having inclination to pharmaceutical promotion.
