Background and key elements of Guidance of Clinical Drug Dependence Research
10.13699/j.cnki.1001-6821.2024.23.029
- VernacularTitle:《药物临床依赖性研究技术指导原则(试行)》起草背景及要点内容
- Author:
Hao ZHANG
1
;
Zhao-yun WANG
1
;
Qiang LI
1
;
Duan-duan CONG
1
;
Yan-zhe SUN
1
;
Li-qing WANG
1
;
Ying GENG
1
Author Information
1. 国家药品监督管理局药品审评中心,北京 100076
- Publication Type:Journal Article
- Keywords:
central nervous system drug;
clinical drug dependence;
drug of potential abuse;
guidance
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(23):3509-3515
- CountryChina
- Language:Chinese
-
Abstract:
At present,the research and development of drugs in the central nervous system(CNS)field in China is progressing rapidly.In the process of CNS drug development,it is necessary to monitor the potential drug abuse as early as possible,and evaluate the drug dependence through comprehensive evaluation of pharmaceutical,non clinical and clinical evidence.At present,both European Medicines Agency(EMA)and Food and Drug Administration(FDA)have issued relevant guidelines to manage drugs with potential abuse,and China's National Medical Products Administration has also released the guidance of non-clinical drug dependence research.Therefore,in order to guide the development of CNS drugs,monitor the potential drug abuse,ensure patient medication safety,and guide clinical rational medication,On 28 September 2022,guidance of clinical drug dependence research was published.Clinical dependency assessment is an important part of the safety evaluation of drugs with abuse potential.Due to its special research purpose and evaluation requirements,its research process and data sources run through the entire clinical research.Analysis of relevant data generated throughout the clinical research process,evidence about drug clinical dependency is obtained.This article will introduce the background and key elements of this guidance.
