Your Navigation:PCAR > Abstract
Search pcar
检索项:
检索词:
Abstract
Pharmaceutical Care and Research: 2018; 18(3):225-228
DOI: 10.5428/pcar20180319
Introduction to the management mode of clinical trial drugs in GCP pharmacy
1. HAN ShanYing(Department of Pharmacy,People’s Hospital of Haikou City,Haikou 570208,China 1339566230@qq.com)
2. ZHONG ShaoJin(Department of Pharmacy,People’s Hospital of Haikou City,Haikou 570208,China )
3. QIU YingQi(Department of Pharmacy,People’s Hospital of Haikou City,Haikou 570208,China )
ABSTRACT  Objective: To introduce the management mode of experimental drugs in People’s Hospital of Haikou City,improve the management level,and ensure the quality of clinical trials.Methods: A management system of GCP pharmacy,including pharmacy document management,equipment management,drug administrator qualification,and standard operating procedures for the receipt,storage,distribution,recovery and retention of experimental drugs was established according to the GCP requirements and the actual conditions of the hospital.The problems that existed in management were summarized,countermeasures and suggestions for improvement were proposed.Results and Conclusion: The hospital has established a good management system for testing drugs in the GCP pharmacy.The standard operating procedures are highly practical and basically meet the needs of various clinical trials.The pharmacists play an active role in the whole course of clinical trials,so that they can guarantee the safety and quality of clinical trials.
Welcome to PCAR! You are the number 71 reader of this article!
Please cite this article as:
HAN ShanYing,ZHONG ShaoJin,QIU YingQi,. Introduction to the management mode of clinical trial drugs in GCP pharmacy[J]. Pharmaceutical Care and Research / yao xue fu wu yu yan jiu. 2018; 18(3): 225-228.
References:
1. GUO RuiChen.Consistency evaluation of me-too drugs:opportunities and challenges [J].Chin Med News,2016,31(13):21.In Chinese.
2. State Food and Drug Administration.Good clinical practice(No.3 decree by SFDA) [EB/OL].(2003-08-06)[2017-06-04].http://www.sda.gov.cn/WS01/CL0053/24473.html.In Chinese.
3. State Food and Drug Administration.Technical guidelines for the study of bioavailability and bioequivalence of chemical agents in human body[EB/OL].(2005-03-18)[2017-06-04].http://www.sda.gov.cn/WS01/CL1616/83421.html.In Chinese.
4. YUAN WeiAn,LI Zhen,JIANG Jian.Thinking and practice about quality control of clinical drug trials[J].Pharm Care Res,2014,14(4):298-300.In Chinese with English abstract.
5. WANG HuaiFu.Practice experience of pharmacy drug management in drug clinical trial institution of our hospital[J].China Pharmacy,2015,26(28):3909-3911.In Chinese with English abstract.
6. LIU XiaoFang,ZHANG Hong,LI Ying,et al.Study on the application of information management system for clinical trials[J].Chin J Clin Res,2015,28(3):381-385.In Chinese.
《药学服务与研究》杂志社 All Rights Reserved 网站备案号:鲁B2-20061008
·地址:上海市杨浦区长海路168号18号楼东三楼 邮政编码:200433
·联系电话(传真):86-21-65519829, 021-31162330
·电子邮件:PharmCR@vip.163.com
·技术支持:中国康网
管理员入口