Transfer of Impurities Determination Methods: Comparative Testing, Validation, Acceptance Criteria (Review)

Q3 Pharmacology, Toxicology and Pharmaceutics
N. A. Epshtein
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引用次数: 1

Abstract

Introduction. Different approaches are used for transfer of impurities determination methods. In most cases, comparative testing of samples or partial validation of methods is performed. At the same time, a number of issues important for practice are still relevant.Text. The features of methods validation and comparative testing of samples during the transfer of impurities determination methods are considered. Potential acceptance criteria – requirements to the permissible difference between results of transmitting and receiving laboratories – are given. The calculation formulas of the TOST test are considered, and the critical condition for the comparative testing of samples is given. The key points that should be taken into account when transferring the methods are discussed.Conclusion. The data and recommendations are presented, which are important for increasing the reliability of the transfer of the impurities determination methods.
杂质测定方法的转移:比较测试、验证、验收标准(评审)
介绍。不同的方法用于杂质测定方法的转移。在大多数情况下,对样品进行比较测试或对方法进行部分验证。与此同时,一些对实践很重要的问题仍然是相关的。考虑了杂质测定方法转移过程中方法验证和样品比对试验的特点。给出了潜在的可接受标准——对发送实验室和接收实验室结果之间允许差异的要求。考虑了TOST试验的计算公式,给出了试样对比试验的临界条件。讨论了方法转移时应注意的要点。本文给出的数据和建议对提高杂质测定方法传递的可靠性具有重要意义。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Drug Development and Registration
Drug Development and Registration Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
1.20
自引率
0.00%
发文量
61
审稿时长
8 weeks
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