Developing process of guide on methodological standards in pharmacoepidemiology (T/CPHARMA 002-2019)
10.3760/cma.j.issn.0254-6450.2019.10.003
- VernacularTitle: 《中国药物流行病学研究方法学指南(T/CPHARMA 002-2019)》团体标准制定过程
- Author:
Yang XU
1
;
Chengyi DING
1
;
Lin ZHUO
2
;
Siyan ZHAN
1
Author Information
1. Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China
2. Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China
- Publication Type:Guideline
- Keywords:
Pharmacoepidemiology research;
Guideline development;
Methodology
- From:
Chinese Journal of Epidemiology
2019;40(10):1186-1190
- CountryChina
- Language:Chinese
-
Abstract:
Pharmacoepidemiology refers to the use of epidemiological research methods in studying the application and use of drugs in large populations to evaluate the safety and efficacy of medical products. Therefore, standardized pharmacoepidemiology research is the basis of the above work. Based on systematic reviews of national and international pharmacoepidemiological methodological standards and guidelines, and in combination with Chinese medical and health practice and experts’ opinions, the Professional Committee of Pharmacoepidemiology of Chinese Pharmaceutical Association developed the group standard, guide on methodological standards in pharmacoepidemiology (T/CPHARMA 002-2019), to better guide the work of pharmacoepidemiology. The guideline was designed to provide advice and reference for pharmacoepidemiology research by government, regulatory agencies, research institutions, and pharmaceutical manufacturers in China.