Article(id=1236331827049320624, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331822909550881, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1683302400000, acceptedDateStr=2023-05-06, onlineDate=1772694077503, onlineDateStr=2026-03-05, pubDate=1701273600000, pubDateStr=2023-11-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694077503, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694077503, creator=13701087609, updateTime=1772694077503, updator=13701087609, issue=Issue{id=1236331822909550881, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='22', pageStart='2225', pageEnd='2328', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694076516, creator=13701087609, updateTime=1772696919965, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236343749253591892, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331822909550881, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236343749253591893, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331822909550881, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2293, endPage=2299, ext={EN=ArticleExt(id=1236331827305173180, articleId=1236331827049320624, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=How to develop the analytical target profile of analytical procedure, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The analytical target profile (ATP) of analytical procedure is the key content in the development of analytical procedure and even the whole life cycle management, and the content had been explicitly proposed in the latest release of ICH Q14 and USP <1220 in 2022. The steps of establishing ATP were discussed in detail in this paper based on the latest research progress in the whole life cycle of analytical procedure at home and abroad, which included: ① Collect relevant prior knowledge. ② Determine the performance characteristics of the procedure to be reported according to the relevant critical quality attribute (CQA) to be detected. ③ Study and formulate the acceptance criteria of corresponding performance characteristics. ④ Construct the ATP of existed analytical procedure using retrospective research. ⑤ Optimize and update the primary ATP. It is expected that the paper could provide reference for methodological researchers at home and abroad and bring convenience to the development and evaluation for the whole life cycle of analytical procedure.

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方法的分析目标概要（ATP）是药品分析方法研发和全生命周期管理中的关键内容，该内容在2022年最新发布的ICH Q14和USP 〈1220〉中明确提出。本文结合国内外对分析方法全生命周期研究的最新进展，详细探讨了ATP的建立步骤，即：① 收集相关先验知识。② 根据所需检测的相关关键质量属性（CQA），确定需报告的方法性能特性。③ 研究并制定相应性能特性的接受标准。④ 采用回顾性研究方式构建已有方法的ATP。⑤ ATP的优化更新。期望本文能为国内外方法学研究者提供参考，为分析方法的建立和全生命周期评估带来便利。

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²China Pharmaceutical University, Nanjing 210009, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236331828240503038, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331827049320624, authorId=1236331828026593518, language=CN, stringName=杨美玲, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=^{1, 2}, address=¹国家药品监督管理局化学药品质量研究与评价重点实验室，中国食品药品检定研究院， 北京 102629
²中国药科大学，南京 210009, bio={"content":"

杨美玲，女，硕士研究生，主要从事药品检测、方法学和质量标准研究。E-mail: meilingyang98@163.com。

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杨美玲，女，硕士研究生，主要从事药品检测、方法学和质量标准研究。E-mail: meilingyang98@163.com。

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