- [网络] 方法确认；方法验证；方法确效
下载手机词典可随时随地查词查翻译
method validation中文什么意思
例句与用法
- 更多例句： 上一页 下一页
- this guidance, when finalized, will replace the fda guidance for industry on submitting samples and analytical data for methods validation ( february 1987 )
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 methods validation process for analytical procedures begins with the planned and systematic collection by the applicant of the validation data to support the analytical procedures
分析方法的验证过程是从申请者有计划地系统性收集验证资料以支持分析方法开始的。 - for example, many bioassays are based on animal challenge models, 39 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。 - though more specific analytical issues concerning microbiological assay radioimmunoassay and stereoisomer assay were not examined, this article should provide good guidance to pharmaceutical chemists to properly perform analytical method validation and carry out routine analysis
作者将为从事分析方法认证的工作者提供指南，但对专属分析方法的认证如微生物分析，同位素免疫分析及立体异构体分析未及论述。 - general guidance regarding analytical procedures and methods validation information to be submitted for phase 2 or phase 3 studies will be provided in the fda guidance for industry inds for phase 2 and 3 studies of drugs, including specified therapeutic biotechnology-derived products, chemistry, manufacturing, and controls content and format, when finalized ( draft guidance published april 1999 )
关于在第1阶段研究所需提交的分析方法和方法验证资料方面的指南，发起人可以参考fda的指南：药品（包括结构确定的，有疗效的，生物技术产品）第1阶段研究的ind申请的内容和格式（1995年11月）。