| 摘要: |
| 采用体内生物等效性试验的方法开展一致性评价是仿制药申请的基础，生物等效性试验首选药动学研究的方法，而药动学中生物样品分析是最为重要的环节，它将直接影响药品的安全性和有效性，为生物等效性试验的结果做出关键性决定。目前我国的生物样品分析质量还有很大提升空间，基于此，本文根据相关指导原则，结合工作实际，针对生物等效性试验中生物样品分析方法的建立、验证、测试、记录和注意事项等，探讨生物等效性试验中生物样品分析的关键问题。 |
| 关键词: 生物等效性试验 方法学 生物样品分析 |
| DOI：10.13748/j.cnki.issn1007-7693.2019.07.025 |
| 分类号:R917 |
| 基金项目: |
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| Key Points of Bioanalysis in Bioequivalence Study |
|
HU Lanlan, TANG Jianlin
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National Drug Clinical Trial Institution, the Second Affiliated Hospital, Army Medical University, Chongqing 400037, China
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| Abstract: |
| To use bioequivalence study on consistency evaluation is the basis of the generic drug application. Pharmacokinetics is the optimal method used for evaluating bioequivalence. The most important aspect in pharmacokinetic is bioanalysis, which will directly affect the safety and effectiveness of drugs, and is also the key point for the results of bioequivalence study. Previous analytical results suggest that there is great room for improvement in data quality of bioanalysis carried out in our country. Thus, the aim of the study is to discuss the key points of method establishment, validation, testing, and recording in bioanalysis of bioequivalence based on the relevant guidelines and our actual work. |
| Key words: bioequivalence methodology bioanalysis |
