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在对新药申报的样本分析过程中,需要接受药政管理部门的严格监管,以往的研究结果表明,我国的药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药物样本分析的法规和质量体系建设情况以及目前在药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。
In the process of sample analysis of the new drug application, it needs to be strictly supervised by the administrative department of medicine and government. Previous research results show that there is still much room for improvement in the quality analysis of drug samples in our country. This article reviews the domestic and international regulations and quality system for the analysis of drug samples and the problems that need attention at present in the methodology development, verification and testing of drug sample analysis.