本版越来越冷清了，可能大家都很忙。为了给版面增加点人气，我学着影子姐继续开展有奖翻译的活动。这次选取的是一篇关于分析方法验证的指南草案。希望大家有空的时候就参与一下，这样我就有信心坚持把这个活动办下去啦。 Guidance for Industry Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation 先发几句试试。
101：I. INTRODUCTION
This guidance provides recommendations to applicants on submitting analytical procedures, validation data, and samples to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. This guidance is intended to assist applicants in assembling information, submitting samples, and presenting data to support analytical methodologies. The recommendations apply to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), product license applications (PLAs), and supplements to these applications.
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