Article(id=1291707178642076219, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.24.020, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1742832000000, receivedDateStr=2025-03-25, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896590146, onlineDateStr=2026-08-05, pubDate=1766851200000, pubDateStr=2025-12-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896590146, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896590146, creator=13701087609, updateTime=1785896590146, updator=13701087609, issue=Issue{id=1291706966187991876, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='24', pageStart='3451', pageEnd='3600', issueExtLink='null', onlineDate='null', pubDate='1766851200000', pubDateStr='2025-12-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896539494, creator='13701087609', updateTime=1785998798662, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292135872292479273, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292135872296673578, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3575, endPage=3579, ext={EN=ArticleExt(id=1291707178893734460, articleId=1291707178642076219, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=General considerations for the design of bioequivalence studies of thioctic acid tablet, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

Thioctic acid is widely used in clinical treatment of diabetic peripheral neuropathy. The human bioequivalence (BE) study of thioctic acid tablet should follow the relevant regulations and guidelines, and fully consider the particularity of the clinical use of this product. It is recommended to adopt a single dose, two preparations, two sequences, partial or complete repeated crossover study design, and select the reference preparations that have been publicly released for the fasting test. In addition, researchers should pay attention to the Chinese version of The Internationevl Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M13A and its Q&A document, as well as the BE study ideas of similar drugs. This article takes the BE study of thioctic acid tablet as an example to provide in-depth guidance for the research.

, authors=Fang LI, Li-li HA, Li-li LIU, Dong LI, Man-ru REN, Yu ZHOU, authorsList=Fang LI, Li-li HA, Li-li LIU, 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=1291707180810531389, articleId=1291707178642076219, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=硫辛酸片生物等效性研究的一般设计要求及相关考虑, 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=

硫辛酸在临床上被广泛用于治疗糖尿病并发的周围神经病变。硫辛酸片的人体生物等效性（BE）研究应遵循相关法规和技术指导原则，同时充分考虑其临床使用方式的特殊性，建议采用单次给药、两制剂、两序列、部分或完全重复交叉设计，选择已发布的参比制剂进行空腹试验。另外，研究者仍需关注国际人用药品注册技术协调会（ICH）《M13A:口服固体速释制剂的生物等效性》及其问答文件的中文版征求意见稿，以及类似药物BE研究思路。本文以硫辛酸片为例，旨在为我国口服固体制剂特殊给药方法的仿制药研发工作提供深入指导。

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李芳（1984-），女，中级工程师，主要从事临床药理学技术审评工作

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李芳（1984-），女，中级工程师，主要从事临床药理学技术审评工作

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