Article(id=1291707154977804914, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.23.018, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1745769600000, receivedDateStr=2025-04-28, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896584504, onlineDateStr=2026-08-05, pubDate=1765900800000, pubDateStr=2025-12-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896584504, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896584504, creator=13701087609, updateTime=1785896584504, updator=13701087609, issue=Issue{id=1291707045514858818, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='23', pageStart='3301', pageEnd='3450', issueExtLink='null', onlineDate='null', pubDate='1765900800000', pubDateStr='2025-12-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896558407, creator='13701087609', updateTime=1785896663780, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707487678390577, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707487682584882, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3426, endPage=3429, ext={EN=ArticleExt(id=1291707155711808115, articleId=1291707154977804914, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=General considerations for the design of bioequivalence studies of acetylcysteine granules, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

Acetylcysteine is a commonly used clinical drug, and its free thiol group can break the disulfide bond (S-S) in the glycoprotein peptide chain in sputum, thereby reducing sputum viscosity and promoting sputum excretion. It is an endogenous substance. When conducting bioequivalence studies, it is necessary to fully consider and design aspects such as the research type, dosage, blood collection point design, bioequivalence evaluation, etc., and fully evaluate the impact of endogenous acetylcysteine on bioequivalence evaluation. This article integrates the pharmacokinetic (PK) characteristics of acetylcysteine granules along with the bioequivalence research conducted on its generic version prior to domestic marketing. Through this approach, it comprehensively explores the general design requirements and key considerations for conducting bioequivalence studies on this product.

, authors=Li-li LIU, Fang LI, Li-li HA, Dong LI, Man-ru REN, Yu ZHOU, authorsList=Li-li LIU, Fang LI, Li-li HA, Dong LI, Man-ru REN, Yu ZHOU, authorCompany=null, correspAuthors=Yu ZHOU, 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=1291707156148015732, articleId=1291707154977804914, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=乙酰半胱氨酸颗粒生物等效性研究设计的一般考虑, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

乙酰半胱氨酸分子中的游离巯基能使痰液中糖蛋白多肽链中的二硫键（S-S）断裂，从而降低痰液粘度，促进痰液排出，属于临床常用药物。它是半胱氨酸的衍生物，也是谷胱甘肽的前体，是可由机体产生的一种内源性物质。在开展生物等效性研究时需对研究类型、给药剂量、釆血点设计、生物等效性（BE）评价等方面进行充分考虑与合理设计，充分评估内源性乙酰半胱氨酸对于生物等效性评价的影响。本文结合乙酰半胱氨酸颗粒的药代动力学（PK）特征，并基于其仿制药在国内上市前所开展的生物等效性研究情况，系统探讨了本品生物等效性研究的设计要求及相关考虑。

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刘力力（1986-），女，助理研究员，主要从事临床药理学技术审评工作

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刘力力（1986-），女，助理研究员，主要从事临床药理学技术审评工作

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