| 王丽,王勇,杨昌雄.非临床研究中大分子生物分析方法验证报告审核方法[J].中国药事,2022,36(4):399-403 |
| 非临床研究中大分子生物分析方法验证报告审核方法 |
| Audit Method for Validation Report for Macromolecule Bioanalytical Method in Nonclinical Laboratory Studies |
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| DOI：10.16153/j.1002-7777.2022.04.005 |
| 中文关键词: 大分子 生物分析方法验证报告 药物非临床研究 审核 数据 |
| 英文关键词: macromolecule validation report for bioanalytical method nonclinical laboratory study audit data |
| 基金项目:江苏省新药一站式高效非临床评价公共服务平台建设(编号 BM2021002) |
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| 中文摘要: |
| 目的：掌握大分子生物分析方法验证报告审核的方法和原则，确保验证报告的科学性、合规性和完整性。方法：将完整的生物分析方法验证报告和原始记录拆分为原始记录、数据及数据处理、验证报告，分别对三部分进行全面系统性审核，最后将审核的结果进行分析和汇总。结果与结论：通过系统性的审核，熟练掌握审核的方法和要点，提高大分子生物分析方法验证报告的审核效率，提升报告质量，满足机构SOPs和国内外法律法规的要求，推进客户药物研发和申报进程。 |
| 英文摘要: |
| Objective: To master the methods and principles of report audit of macromolecule bioanalytical method validation in order to ensure scientificity, compliance and integrity of the validation report. Methods: The complete validation report of bioanalytical method and the original records were divided into three parts: original records, data and data processing and validation report. Aftert the three parts had been comprehensively and systematically reviewed, the audit results were analyzed and summarized. Results and Conclusion: Through systematic audit, the audit methods and the key points are mastered and the audit efficiency and quality of the validation report for macromolecule bioanalytical method are improved so as to meet the requirements of SOPs, domestic and foreign laws and regulations and promote the proceeding of drug R&D and application. |
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