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Analytical Procedures must be Validated. 分析操作规程必须经过验证。
A detailed description of the analytical procedures used to characterize the reference standard. 用于界定标准品的分析程序的详细叙述。
All chromatographic analytical procedures should include system suitability testing and criteria. 所有的色谱分析方法都应当要有系统适应性实验及相应的合格标准。
FDA intends to provide guidance in the future on postapproval changes in analytical procedures. FDA打算在将来要提供分析方法批准后变更方面的指南。
Analytical procedures outside the scope of the ICH guidances should still be validated. 对于超出ICH指导原则范围的分析方法也是需要验证的。
The review chemist evaluates the analytical procedures and validation data submitted in the NDA or ANDA. 审评化学家会对NDA或ANDA中的分析方法和验证资料进行评审。
The principles, analytical procedures and calculation of the method were introduced. 介绍了该方法的原理、分析步骤及计算方法。
Biological and/ or immunochemical activity should be assessed using the same analytical procedures used to determine product potency. 确定生物和/免疫化学活性的分析方法应当要和用来确定产品效力的分析方法一样。
The review committee chair may request analytical testing by CBER laboratory analysts to evaluate the applicant=s analytical procedures and verify the test results. 评审委员会主席会要求CBER实验室的分析人员进行分析实验对申请者的分析方法进行评估，并确认其分析结果。
Biological and/or immunochemical activity should be assessed using the same analytical procedures used to determine product potency. 确定生物和/或免疫化学活性的分析方法应当要和用来确定产品效力的分析方法一样。
A description of analytical procedures from any other published sources should be provided, because the referenced sources may not be readily accessible to the reviewer. 对于从其它公开发表的文献上获得的分析方法，应当要对其进行叙述，因为评审官可能并不能很方便的获得这些文献。
All analytical procedures should be fully developed and validation completed when the NDA, ANDA, BLA, or PLA is submitted. 在递交NDA，ANDA，BLA或PLA时，所有的分析方法都应当要开发出来，并得到验证。
In general, validated analytical procedures should be used, irrespective of whether they are for in-process, release, acceptance, or stability testing. 一般来说，应当要应用已验证过的分析方法，而不论其是被用于过程控制，放行，合格或稳定性实验。
Analytical procedures should be performed early in the audit so to help the auditor determine areas that need to be more thoroughly investigated. 该步骤应在审计的早期进行，以便审计师能决定哪些关键区域需要更透彻的审查。
The review chemists and laboratory analysts determine the suitability of the analytical procedures for regulatory purposes. 审评化学家和实验室分析家会从法规的角度确定该分析方法的适用性。
Data must be available to establish that the analytical procedures used in testing meet proper standards of accuracy and reliability (21 CFR 211.165(e) and 211.194(a)(2)). 必须要有资料来论证所用的分析方法是符合一定的准确度和可靠性标准的。
He tried to put a bold face on his failure. 他对自己的失败装出一副满不在乎的样子。
The cake we made was somewhat of a failure. 我们做的蛋糕不大成功。
METHODS:Based on the requirements on drug registration in Europe and the USA,we expounded the validation on analytical procedures and put forward some concrete methods. 方法:结合欧美原料药注册管理的要求,对其中的分析方法验证部分进行全面阐述,并提出具体的操作方法。
For BLAs, PLAs, and their supplements, the analytical procedures and their validation are submitted as part of the license application or supplement and are evaluated by the review committee. 对于BLA，PLA及它们的补充，在所提交的许可证申请中应当要有分析方法和方法验证这部分的资料，审评委员会会对这部分资料进行评审。