Any changes in the methods resulting from the review of the application may require resubmission of the methods validation package.
对申请进行评审后，如要对分析方法作必要修改的话，则需要重新递交分析方法验证资料。
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。
Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use.
分析方法验证是论证某一分析方法适用于其用途的过程。
This guidance, when finalized, will replace the FDA guidance for industry on Submitting Samples and Analytical Data for Methods Validation (February 1987).
对于本指南中未提及的关于分析方法验证和资料提交方面的问题，请向FDA相关的化学评审人员咨询。
This guidance, when finalized, will replace the FDA guidance for industry on Submitting Samples and Analytical Data for Methods Validation (February 1987).
对于本指南中未提及的关于分析方法验证和资料提交方面的问题，请向FDA相关的化学评审人员咨询。
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