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This article explained the purpose of analytical method validation, pointed out that there are many problems and misunderstandings about method validation in drug research and development, and gave some opinions and suggestions according to the authors' experience, expecting for higher demand from the regulatory authorities.

, authors=Fei LI¹, Yun LI², authorsList=Fei LI, Yun LI, authorCompany=null, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322245745525249007, articleId=1322245745063875565, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=对药物研发中分析方法验证的几点考虑, columnId=1236331159400018080, journalTitle=中国新药杂志, columnName=新药注册与审评技术, runingTitle=null, highlight=null, articleAbstract=

本文对分析方法验证的内涵进行了进一步阐述，指出了目前药物研发中在分析方法验证方面存在的问题以及误区，给出了作者的见解和建议，并提出了更高的要求和期望。

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李飞，男，化药药学主审审评员，主管药师，主要从事药品审评工作。E-mail：lifei@cde.org.cn。

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李飞，男，化药药学主审审评员，主管药师，主要从事药品审评工作。E-mail：lifei@cde.org.cn。

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