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- Method validation data must be summarized into a report that is clear and easy to follow. 方法确认数据必须总结为清晰和易于执行的报告。
- Conduct to prepare and modify SOPs, Method Validation Protocol and Report, GMP Documents, etc. 指导SOP、方法验证方案和报告、GMP文件的制定和改进。
- The information required for an adequate analytical method validation for either in vitro or in vivo biopharmaceutical studies is discussed in this article. 摘要本文将讨论生物药剂学体内、体外试验分析方法论证的必要依据。
- And the HPLC-ELSD analytical method has been developed for the assay of the Astragaloside in the main active principle Radix Astragali. The average recovery is 95.33%, with RSD of 1.52%. The method validation has also been examined. 采用HPLC-ELSD法对君药黄芪中黄芪甲苷的含量进行了测定，平均回收率为95.;33%25，RSD为1
- METHODS Validation of microbial limit was tested according to Pharmacopoeia of China 2005 edition. 方法按中国药典2005版微生物限度检查方法进行验证试验。
- Preparing for a Method Validation Study 方法确认研究的准备
- This guidance, when finalized, will replace the FDA guidance for industry on Submitting Samples and Analytical Data for Methods Validation( February1987). 本指南，一旦定稿，将取代fda于1987年2月份发布的工业指南：分析方法验证所需提交的样品和分析资料。
- The method seems good but it needs to be tried out. 这个方法似乎不错，但需要试验一下。
- The initial experiment shows that the motor performance is very close with the simulation result and it proves the design method validity. 初步实验结果显示实际马达性能与模拟结果非常接近，证实了整个马达设计方法的有效性。
- Such marks are cumulated to get the final evaluation of the SC.In the last, the thesis confirmed this method validity through the examples. 最后，论文通过支持向量机环境下仿真实验验证了基于支持向量机的供应链绩效评价方法的有效性。
- Other Methods Validation Information Methods validation information should also include: Data to demonstrate the stability of all analytical sample preparations through the time required to complete the analysis. 其它验证资料分析方法验证资料还应当要包括:说明所有分析制备样品在完成分析所需的时间内的稳定性的资料。
- XI. METHODOLOGY Sections II through IX provide general information on the submission of analytical procedures and methods validation information, including validation characteristics. Additional information on certain methodologies is provided below. II章到第IX章提供了分析方法和分析方法验证资料方面的基本信息,包括验证项目。下文就一些具体的方法给出了说明
- For example, many bioassays are based on animal challenge models, immunogenicity assessments, or other immunoassays that have unique features that should be considered when submitting analytical procedure and methods validation information. 比如说，许多生物分析是建立在动物挑战模式，免疫原性评估或其它有着独特特性的免疫分析基础上的，在递交分析方法和分析方法验证资料时需考虑这些独特的性质。
- For CDER products, the number of sets of samples that should be submitted for methods validation will be identified in the instructions forwarded to the applicant by the FDA laboratory. 对于CDER产品，FDA实验室会告诉申请者所需递交样品的量。
- Keywords metalloscope;digital photomicrographing;method validation; 显微镜;数码照相;方法确认;
- I can't claim infallibility for this method. 我不敢说这方法绝对有效。
- Summer fallow is the best method of destroying weeds. 夏季休耕是消灭杂草的最好办法。
- In order to determine equivalent method validity, laboratory laser simulation system (LSS) was employed to measure the single event upset threshold for some electronic devices and integrated circuits. 应用实验室的激光模拟单粒子效应试验系统，开展了几种器件和集成电路的单粒子翻转实验研究。
- Popularizing this new method is not an easy job. 推广这种新方法不是件容易的工作。
- This is not an economical method of heating. 这不是一种经济的取暖方式。
