Introduction of Association The British Pharmaceutical Industry ’ s guidelines for phase 1 clinical trials of 2012
10.13699/j.cnki.1001-6821.2014.07.026
- VernacularTitle:2012版英国制药工业协会Ⅰ期临床试验指导原则介绍
- Author:
Yun KUANG
1
;
Jie HUANG
;
Cheng-Huai JIN
;
Ye HUA
;
Guo-Ping YANG
Author Information
1. 中南大学药学院
- Keywords:
phase 1 clinical trial;
Association The British Pharmaceuti-cal Industry;
guidelines;
human verification;
risk assessment
- From:
The Chinese Journal of Clinical Pharmacology
2014;(7):642-646
- CountryChina
- Language:Chinese
-
Abstract:
Phase 1 clinical trials is a key step for new drugs from basic experiments to human verification.Developed countries have formulated the corresponding laws , regulations and policies and guiding principles.Association The British Pharmaceutical Industry ( ABPI ) released a 2012 version of guidelines for phase 1 clinical trials.It provided professional guidances for some important problems in phase 1 clinical trials ( such as risk assessment , contracts and agreements , confidentiality , subjects , in-vestigational medicinal products and so on ).This paper makes a brief in-troduction of guiding principles for phase 1 clinical trials on the 2012 ver-sion of the ABPI.
