药品分析方法转移类型与程序

详细信息    查看全文 | 推荐本文 |

英文篇名：Types and procedures of the transfer of drug analytical methods 作者：孙一平 ; 刘戈 ; 李春刚 英文作者：SUN Yiping;LIU Ge;LI Chungang;Shanghai Shyndec Pharmaceutical Co., Ltd.;Shanghai Shyndec Pharmaceutical(Haimen) Co., Ltd.; 关键词：分析方法转移类型 ; 对比试验 ; 分析方法转移程序 ; 实验设计 ; 接收标准 英文关键词：types of transfer of analytical methods;;comparative test;;transfer of analytical method;;experimental design;;acceptance criteria 中文刊名：SYIY 英文刊名：Shanghai Medical & Pharmaceutical Journal 机构：上海现代制药股份有限公司上海事业部;上海现代制药海门有限公司; 出版日期：2019-02-10 出版单位：上海医药 年：2019 期：v.40;No.520 语种：中文; 页：SYIY201903032 页数：4 CN：03 ISSN：31-1663/R 分类号：79-82

摘要

本文从分析方法转移与方法验证和确认的概念着手,介绍其区别与不同适用范围。着重论述分析方法转移的方式和程序,并探讨了分析方法转移中的实验设计与接收标准。
        This article started with the concept of transfer, validation and confirmation of analytical methods and introduced its differences and different scopes of application. Meanwhile, the methods and procedures for the transfer of analytical methods were focused on and the experimental design and acceptance criteria in the transfer of analytical methods were also explored.

引文

[1]许明哲,黄宝斌,杨青云,等.分析方法验证、转移和确认概念解析[J].药物分析杂志,2015,35(1):169-175.
    [2]许明哲,黄宝斌,杨青云,等.分析方法转移内容介绍[J]药物分析杂志,2015,35(1):176-182.
    [3]USP36-NF31[M/OL].[2018-05-07].https://max.book118.com/html/2017/0826/130224027.shtm.
    [4]Quattrocchi O,Martin G,Runser D,et al.Transfer of analytical procedures:a proposal for a new general information chapter[EB/OL].[2018-05-25].https://www.researchgate.net/publication/253451431_Transfer_of_Analytical_Procedures_A_Proposal_for_a_New_General_Information_Chapter.
    [5]国家食品药品监督管理局药品认证管理中心.药品GMP实施指南--质量控制实验室与物料系统[M].北京:中国医药科技出版社,2011:143-145.
    [6]ISPE.ISPE Good Practice Guide-Technology Transfer[M].Belgium:ISPE Headquarters,2003:23-34.
    [7]PDA Technical Report No.65(TR 65),Technology Transfer[EB/OL].[2018-05-07].https://wenku.baidu.com/view/f6af6b26b0717fd5360cdcdc.html.