生物活性检测方法验证专栏

生物活性检测方法的定义及分类辨析*

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  • 1.中国食品药品检定研究院 国家药品监督管理局化学药品质量研究与评价重点实验室, 北京 102629;
    2.北京民海生物科技有限公司, 北京 102609
第一作者 李 娜 Tel:18612408509;E-mail:lln0809@163.com;杜 颖 Tel:(010)53851583;E-mail:dy9630@nifdc.org.cn
** Tel:(010)53851589;E-mail:tandj@nifdc.org.cn

收稿日期: 2022-04-18

  网络出版日期: 2024-06-24

基金资助

* 国家药品标准制修订课题(2022Y09);中检院质量安全与能力建设项目

Definition and taxonomy of biological method*

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  • 1. NMPA key Lab for Quality Research and Evaluation of Chemical Drug, National Institutes for Food and Drug Control, Beijing 102629, China;
    2. Beijing Minhai Biotechnology Co., Ltd., Beijing 102609, China

Received date: 2022-04-18

  Online published: 2024-06-24

摘要

目的: 探索生物活性检测方法的定义和系统分类规范,为深入认识并全面理解生物活性方法的本质提供思路。方法: 根据生物活性检测方法的属性特征搭建生物活性方法分类框架,并阐述其分类意义。结果: (1)生物活性检测方法的定义在不同领域中的关注点不同,而导致侧重点不同,但主题思想基本一致。(2)在生物活性检测方法中,效价及其衍生术语均有明确的内涵和外延,准确使用这些术语可使表达更加专业和清晰。(3)生物活性检测方法可以根据所检测的生物效应直接与否、测定所用生物受试体特征、生物活性反应的性质和机理,以及活性检测结果的数据类型等众多属性进行划分。结论: 对生物活性检测方法进行科学规范地定义和分类,不仅有利于统一该类方法在应用时的表达规范性,还可深入了解方法的特性,为进一步理解方法,以及科学应用方法和改进方法提供理论依据和技术支撑。

本文引用格式

李娜, 杜颖, 刘翠, 郑学学, 李向群, 谭德讲 . 生物活性检测方法的定义及分类辨析*[J]. 药物分析杂志, 2022 , 42(6) : 931 -936 . DOI: 10.16155/j.0254-1793.2022.06.02

Abstract

Objective: To explore the definition and systematic taxonomy of bioassay method, to provide ideas for better understanding the essence of bioassay. Methods: According to the attribute characteristics of bioassay, the classification framework of bioassay was established and the meaning for the classification was explained. Results: (1) The definition of bioassay has different emphases, mainly due to the different focus in various fields, but the theme was basically the same. (2)Potency and its derivative terms had their definitive connotations and extents in bioassay, and accurate use of these terms could make the expression more professional and clearer. (3) Bioassays could be classified according to many attributes, such as whether directness or not of the biological effect detected, the type of the biological subsector used for assay, the nature and mechanism of the bioassay, and the data type of reportable value of the bioassay. Conclusion: Accurate and standardized definition and classification of bioassay are not only conducive to the standardization of expression for use, but also provide theoretical basis and technical support for further understanding, application and improvement of bioassay.

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