美国FDA分析方法验证指南中英文对照.docVIP

美国FDA分析方法验证指南中英文对照（一） HYPERLINK /mon.php?action=viewspaceop=upitemid=27523uid=2541 上一篇 / HYPERLINK /mon.php?action=viewspaceop=nextitemid=27523uid=2541 下一篇 ?2009-01-05 10:38:15 / 个人分类： HYPERLINK /?uid-2541-action-spacelist-type-blog-itemtypeid-773 GMP/GLP HYPERLINK /?uid-2541-action-viewspace-itemid-27523 \l xspace-tracks#xspace-tracks 查看( 626 ) / HYPERLINK /?uid-2541-action-viewspace-itemid-27523 \l xspace-itemreply#xspace-itemreply 评论( 2 ) / HYPERLINK /?uid-2541-action-viewspace-itemid-27523 \l xspace-itemform#xspace-itemform 评分( 0 / 0 ) 美国FDA分析 HYPERLINK javascript:; \t _self 方法验证指南中英文对照（/library/ShowArticle.asp?ArticleID=69）I. INTRODUCTIONThis 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. 1. 绪论 本指南旨在为申请者提供建议，以帮助其提交 HYPERLINK javascript:; \t _self 分析方法，方法验证资料和样品用于支持原料药和制剂的认定，剂量，质量，纯度和效力方面的文件。 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. 本指南旨在帮助申请者收集资料，递交样品并资料以支持分析方法。这些建议适用于NDA，ANDA，BLA，PLA及其它们的补充中所涉及的原料药和制剂。 The principles also apply to drug substances and drug products covered in Type II drug master files (DMFs). If a different approach is chosen, the applicant is encouraged to discuss the matter in advance with the center with product jurisdiction to prevent the expenditure of resources on preparing a submission that may later be determined to be unacceptable. 这些原则同样适用于二类DMF所涉及的原料药和制剂。如果使用了其它方法，鼓励申请者事先和FDA药品评审中心的官员进行讨论，以免出现这种情况，那就是花了人力物力所准备起来的递交资料后来发现是不可用的。 The principles of methods validation describe