Article(id=1292126381270393785, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.04.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1770739200000, receivedDateStr=2026-02-11, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996535842, onlineDateStr=2026-08-06, pubDate=1772208000000, pubDateStr=2026-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996535842, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996535842, creator=13701087609, updateTime=1785996535842, updator=13701087609, issue=Issue{id=1292126355785802497, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='4', pageStart='451', pageEnd='600', issueExtLink='null', onlineDate='null', pubDate='1772208000000', pubDateStr='2026-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996529766, creator='13701087609', updateTime=1786014519902, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201811952292026, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201811952292027, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=586, endPage=589, ext={EN=ArticleExt(id=1292126381480108986, articleId=1292126381270393785, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Concerns in the bioequivalence study of eliglustat capsules, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

Eliglustat is a first-line oral small molecule drug for the treatment of type 1 Gaucher disease, which can reduce the volume of spleen and liver, and improve anemia and thrombocytopenia. Eliglustat is mainly metabolized by cytochrome P450 2D6 (CYP2D6), and its systemic exposure is significantly affected by CYP2D6 phenotypes. The bioavailability is extremely low in CYP2D6 extensive metabolizers, resulting in the bioequivalence (BE) study results being easily affected by factors other than the preparation itself. This paper analyzed the potential risk factors in the BE study of eliglustat capsules from the aspects of molecular characteristics, biopharmaceutics, pharmacokinetics, food-drug interaction and genetic polymorphism of metabolic enzymes, so as to provide a practical reference for the BE study of the generic research and development of this variety.

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贺锐锐（1986-），女，副主任药师，从事临床药理学技术审评的工作和研究

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贺锐锐（1986-），女，副主任药师，从事临床药理学技术审评的工作和研究

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