Article(id=1291707107057881636, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291707045514858818, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.23.017, 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=1785896573079, onlineDateStr=2026-08-05, pubDate=1765900800000, pubDateStr=2025-12-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896573079, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896573079, creator=13701087609, updateTime=1785896573079, 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=3421, endPage=3425, ext={EN=ArticleExt(id=1291707109540909606, articleId=1291707107057881636, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=General considerations for the design of bioequivalence studies of Lidocaine and Prilocaine Cream, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

Lidocaine and Prilocaine Cream is a topical cream preparation made by a eutectic mixture of lidocaine and prilocaine in a ratio of 1∶1 by weight. Lidocaine and prilocaine are amide-type local anesthetic agents. Both lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. It is clinically used mainly for local anesthesia of the skin for punctures and superficial surgical procedures. Considering this product is a topical preparation, when evaluating its quality and efficacy consistency with the reference preparation, a stepwise comparative study be conducted based on the drug's characteristics, including pharmaceutical, nonclinical, and/or necessary clinical comparative studies, to support the equivalence evaluation of the generic drug the reference preparation. Clinical comparative studies of this product can be human bioequivalence (BE) studies with the reference preparation. In BE studies, the study type, dose and method of administration, application time, PK blood sampling, skin reaction observation, bioequivalence evaluation, and reactivity evaluation should be fully considered and reasonably designed. This article, based on the characteristics of Lidocaine and Prilocaine Cream and the BE study examples before the domestic launch of the same variety of generic drugs, systematically explores the general design requirements and related considerations for the bioequivalence study of this product.

, authors=Li-li HA, Li-li LIU, Fang LI, Dong LI, Man-ru REN, Yu ZHOU, authorsList=Li-li HA, Li-li LIU, Fang LI, 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=1291707112028131879, articleId=1291707107057881636, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=利丙双卡因乳膏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=

利丙双卡因乳膏（Lidocaine and Prilocaine Cream）是利多卡因和丙胺卡因按重量比1∶1混合制备而成的复方乳膏剂。利多卡因和丙胺卡因均为酰胺类局麻药，通过抑制神经冲动启动和传导所需的离子通量来稳定神经细胞膜，从而产生局部麻醉作用。临床上主要用于针穿刺、浅层外科手术的皮肤局部麻醉。本品为皮肤外用制剂，在评估与参比制剂的质量和疗效一致性时，应基于药物特征，采取逐步递进的对比研究，依次开展药学、非临床和/或必要的临床对比研究，以支持仿制药与参比制剂的等效性评价。以PK参数为终点的临床研究是评价仿制药质量和疗效的一种方法。在利丙双卡因乳膏的BE研究中需对研究类型、给药剂量和方法、贴敷时间、采血时间点、皮肤反应性观察、生物等效性评价、皮肤反应性评价等方面进行充分考虑与合理设计。本文基于利丙双卡因乳膏的品种特点及其同品种仿制药在国内上市前所开展的BE研究实例，系统探讨了本品生物等效性研究的一般设计要求及相关考虑。

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哈莉莉（1982-），女，主管药师，主要从事临床药理学技术审评工作

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哈莉莉（1982-），女，主管药师，主要从事临床药理学技术审评工作

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