基于GCP药房的药物临床试验质量管理
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摘要
为了加强试验用药品的管理,国内很多临床试验机构成立了临床试验质量管理规范(GCP)药房。GCP药房作为药物临床试验机构的组成部分,不但要确保试验用药品各环节管理规范,更要保证药物临床试验按照GCP的要求进行。但是,目前国内GCP药房的功能还仅限于管理试验用药品,基本不涉及对药物临床试验质量的管理。本文根据我院GCP药房开展的工作,探讨GCP药房对药物临床试验质量管理的方法。
In order to strengthen the management of investigational products,many domestic clinical trial institutions in China have established good clinical practice( GCP) pharmacies. As a part of the drug clinical trial institution,GCP pharmacy should not only ensure the management of all aspects of the investigational products,but also ensure that the drug clinical trials are conducted in accordance with the requirements of GCP. However,the current function of the domestic GCP pharmacy is limited to the management of investigational products,and basically does not involve the quality management of drug clinical trials. Based on the work carried out by GCP pharmacy in our hospital,in this paper we discussed the quality management methods of drug clinical trials in GCP pharmacy.
In order to strengthen the management of investigational products,many domestic clinical trial institutions in China have established good clinical practice( GCP) pharmacies. As a part of the drug clinical trial institution,GCP pharmacy should not only ensure the management of all aspects of the investigational products,but also ensure that the drug clinical trials are conducted in accordance with the requirements of GCP. However,the current function of the domestic GCP pharmacy is limited to the management of investigational products,and basically does not involve the quality management of drug clinical trials. Based on the work carried out by GCP pharmacy in our hospital,in this paper we discussed the quality management methods of drug clinical trials in GCP pharmacy.
引文
[1]唐铭婧,梅和坤,江学维,等.专职药师在临床试验用药品管理中的重要作用[J].中国新药杂志,2017,26(22):2710-2713.
[2] SHEHAB N,TAMER H. Dispensing investigational drugs:regulatory issues and the role of the investigational drug service[J].Am J Health Syst Pharm,2004,61(18):1882-1884.
[3]刘妤,陆明莹,张田香,等.临床试验用药品管理模式的探讨[J].中国新药与临床杂志,2017,36(9):522-525.
[4]中关村玖泰药物临床试验技术创新联盟.关于公布《临床试验药物中心化管理现场评估标准(征求意见稿)》公开征求意见的通知[EB/OL].[2018-04-08]. http://www. gcpunion.org/web/static/articles/catalog_ff8080815702574c01570867 b549002e/article_ff8080814d7a2f32014d989b19ab02df/ff8080814d7a2f32014d989b19ab02df. html.
[5]国家食品药品监督管理总局.药物临床试验机构管理规定(征求意见稿)[EB/OL].[2018-04-08]. http://www. cfda. gov. cn/WS01/CL0778/215768. html.
[6]杨春梅,黎艳艳,李华荣,等.临床试验药品管理存在的问题及其对策[J].医药导报,2011,30(6):829-830.
[7]熊樱,吴笑春,辛华雯.临床试验用药物与应急信件管理中易忽略的问题与对策[J].中国药师,2011,14(6):868-870.
[8]崔岚,吕琳,戴志凌,等.药物临床试验过程中试验用药品管理的若干问题[J].中国药房,2010,21(9):820-821.
[9]国家食品药品监督管理总局食品药品审核查验中心.药物临床试验数据核查阶段性报告(2015年7月-2017年6月)[EB/OL].[2018-04-08]. http://www. cfdi. org. cn/resource/news/9136. html.
[10]王白璐.药物临床试验质量管理评价研究[D].济南:山东大学,2012.
[11]杨洁,徐文燕,贺晴.我院开展临床试验用药品集中管理的实践体会[J].中国药房,2014,25(41):3860-3862.
[12]刘业娜,王艺,刘韬,等.某临床试验研究中心GCP药房的运作管理[J].今日药学,2016,26(3):213-216.
[13]牛晓也,张晓婷,高玉玲,等.利用信息化技术实现临床试验用药品中心化管理质量与效率共赢[J].中国新药杂志,2018,27(19):2281-2285.
[2] SHEHAB N,TAMER H. Dispensing investigational drugs:regulatory issues and the role of the investigational drug service[J].Am J Health Syst Pharm,2004,61(18):1882-1884.
[3]刘妤,陆明莹,张田香,等.临床试验用药品管理模式的探讨[J].中国新药与临床杂志,2017,36(9):522-525.
[4]中关村玖泰药物临床试验技术创新联盟.关于公布《临床试验药物中心化管理现场评估标准(征求意见稿)》公开征求意见的通知[EB/OL].[2018-04-08]. http://www. gcpunion.org/web/static/articles/catalog_ff8080815702574c01570867 b549002e/article_ff8080814d7a2f32014d989b19ab02df/ff8080814d7a2f32014d989b19ab02df. html.
[5]国家食品药品监督管理总局.药物临床试验机构管理规定(征求意见稿)[EB/OL].[2018-04-08]. http://www. cfda. gov. cn/WS01/CL0778/215768. html.
[6]杨春梅,黎艳艳,李华荣,等.临床试验药品管理存在的问题及其对策[J].医药导报,2011,30(6):829-830.
[7]熊樱,吴笑春,辛华雯.临床试验用药物与应急信件管理中易忽略的问题与对策[J].中国药师,2011,14(6):868-870.
[8]崔岚,吕琳,戴志凌,等.药物临床试验过程中试验用药品管理的若干问题[J].中国药房,2010,21(9):820-821.
[9]国家食品药品监督管理总局食品药品审核查验中心.药物临床试验数据核查阶段性报告(2015年7月-2017年6月)[EB/OL].[2018-04-08]. http://www. cfdi. org. cn/resource/news/9136. html.
[10]王白璐.药物临床试验质量管理评价研究[D].济南:山东大学,2012.
[11]杨洁,徐文燕,贺晴.我院开展临床试验用药品集中管理的实践体会[J].中国药房,2014,25(41):3860-3862.
[12]刘业娜,王艺,刘韬,等.某临床试验研究中心GCP药房的运作管理[J].今日药学,2016,26(3):213-216.
[13]牛晓也,张晓婷,高玉玲,等.利用信息化技术实现临床试验用药品中心化管理质量与效率共赢[J].中国新药杂志,2018,27(19):2281-2285.