符合法规和指南要求的生物样本分析

Bioanalysis performed according to regulations and guidelines

用于新药申报的生物样本分析过程需要接受药政管理部门的严格监管,以往的研究结果提示,我国的生物样本分析质量还存在很大的提高空间。本文回顾了国内外针对生物样本分析的法规和质量体系建设情况以及目前在生物样本分析的方法学开发、确证和测试等方面需要注意的问题,提醒有关人员注意提高生物样本分析的测试数据质量。

Analytical processes of biosamples for the marketing authorization of new drugs are strictly supervised by the state regulatory agents.Previous analytical results suggest that there is great room for improvement in data quality of bioanalysis carried out in our country.The present paper reviews the guidelines and the construction of quality system for the bioanalysis,as well as the problems required to be paid attention to in the method development,validation and assay of biosamples.The purpose of this review is to remind the people involved in bioanalysis of the importance of data quality.