Significance and Implementation Strategy of Incurred Sample Reanalysis in Bioanalytical Method Validation
文献类型：期刊论文
| 作者 | Chen Xiaoyan ; Zhan Yan; Zhong Dafang
|
| 刊名 | Chinese Pharmaceutical Journal
 |
| 出版日期 | 2014 |
| 卷号 | 49期号:13页码:1176-1180 |
| 关键词 | incurred sample reanalysis bioanalytical method validation quantification reproducibility regulatory bioanalysis |
| ISSN号 | 1001-2494 |
| 其他题名 | 生物样品定量分析方法验证中试验样品再分析的意义和对策 |
| 文献子类 | Article |
| 英文摘要 | OBJECITVE To we summarize the background,evolution and implementation of incurred sample reanalysis (ISR) for bioanalysis. METHODS Based on the available guidance documents, research papers and statistical data, some selected case studies are outlined to help understand the root causes of ISR failures and how to prevent and correct the errors. RESULTS AND CONCLUSION ISR program may improve the reproducibility of bioanalytical assays, and has become an integral part of regulatory guidance. To avoid ISR failure,precautions must be taken in the early stage of method development. |
| WOS研究方向 | Pharmacology & Pharmacy (provided by Clarivate Analytics) |
| 语种 | 中文 |
| CSCD记录号 | CSCD:5181919 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/269330]  |
| 专题 | 上海药物代谢研究中心 |
| 通讯作者 | Zhong Dafang |
| 作者单位 | Shangh ai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China. |
| 推荐引用方式 GB/T 7714 | Chen Xiaoyan,Zhan Yan,Zhong Dafang. Significance and Implementation Strategy of Incurred Sample Reanalysis in Bioanalytical Method Validation[J]. Chinese Pharmaceutical Journal,2014,49(13):1176-1180. |
| APA | Chen Xiaoyan,Zhan Yan,&Zhong Dafang.(2014).Significance and Implementation Strategy of Incurred Sample Reanalysis in Bioanalytical Method Validation.Chinese Pharmaceutical Journal,49(13),1176-1180. |
| MLA | Chen Xiaoyan,et al."Significance and Implementation Strategy of Incurred Sample Reanalysis in Bioanalytical Method Validation".Chinese Pharmaceutical Journal 49.13(2014):1176-1180. |
入库方式： OAI收割
来源：上海药物研究所
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