Article(id=1322627032987582728, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627025303622144, 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=1595952000000, acceptedDateStr=2020-07-29, onlineDate=1793268457885, onlineDateStr=2026-10-29, pubDate=1613318400000, pubDateStr=2021-02-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268457885, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268457885, creator=13701087609, updateTime=1793268457885, updator=13701087609, issue=Issue{id=1322627025303622144, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='3', pageStart='193', pageEnd='288', issueExtLink='null', onlineDate='null', pubDate='1613318400000', pubDateStr='2021-02-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268456054, creator='13701087609', updateTime=1793269130792, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322629855401857146, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627025303622144, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322629855406051451, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627025303622144, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=205, endPage=208, ext={EN=ArticleExt(id=1322627033205686537, articleId=1322627032987582728, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Management of bioequivalence trials for endogenous agents, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

Endogenous substances naturally exist in biological bodies. Due to self-regulation mechanism, exogenous substances and the level of endogenous substances, the design of endogenous drugs bioequivalence test becomes complicated and the trails are difficult to implement. From perspectives of good clinical practice, this article analyzes the difficulties and particularities in the aspects of subject selection and management, diet and drinking water management, sample collection and safety management. This paper also summarizes and discusses quality control measures, providing reference for execution management of endogenous drugs bioequivalence trial.

, authors=Jing LIU¹, Ming XU¹, Hong-jiao LIU², Fa-jun ZHOU², Chuan LIU², authorsList=Jing LIU, Ming XU, Hong-jiao LIU, Fa-jun ZHOU, Chuan LIU, authorCompany=null, correspAuthors=Ming XU, Fa-jun ZHOU, Chuan LIU, 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=1322627033558008074, articleId=1322627032987582728, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=内源性药物生物等效性试验规程管理, columnId=1236331162679955859, journalTitle=中国新药杂志, columnName=新药述评与论坛, runingTitle=null, highlight=null, articleAbstract=

作为机体内原有的物质，因自身调节机制，外源性成分、机体内源性物质水平等多种干扰因素，内源性药物生物等效性试验方案设计复杂，增加试验实施难度。本文从受试者的选择和管理、饮食饮水的控制、样本采集、安全监护方面，对试验实施的难点及特殊性进行分析，总结和探讨质量控制措施，对内源性药物生物等效性临床试验执行管理提供参考。

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刘静，女，主要从事药学临床试验方法学研究。E-mail：liujing0632@126.com。

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刘静，女，主要从事药学临床试验方法学研究。E-mail：liujing0632@126.com。

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journalName=null, refType=null, unstructuredReference=施孝金. 《以药动学参数为终点评价指标的化学药物仿制药人体生物等效性研究技术指导原则》解读[J]. 上海医药, 2016, 37(7): 16-17., articleTitle=null, refAbstract=null), Reference(id=1322627036108144948, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products general considerations[P/OL]. [2003]. http://www.fda.gov/cder/guidance/index.html., articleTitle=null, refAbstract=null), Reference(id=1322627036208808245, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=null, journalName=null, refType=null, unstructuredReference=曹国颖, 朱孔彩, 胡欣. 内源性物质药物生物等效性评价的探讨[J]. 中国新药杂志, 2012, 21(13): 1558-1561., articleTitle=null, refAbstract=null), Reference(id=1322627036322054454, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=3, authorNames=null, journalName=null, refType=null, unstructuredReference=张煊, 谢小青, 刘婷立, 等. 内源性物质药物的定量测定及生物等效性评价研究进展[J]. 中国新药杂志, 2011, 20(22): 2221-2228., articleTitle=null, refAbstract=null), Reference(id=1322627036452077879, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=4, authorNames=null, journalName=null, refType=null, unstructuredReference=SANJEEVA D. Assessing the bioequivalence of analogues of endogenous substances (‘endogenous drugs’): considerations to optimize study design[J]. Br J Clin Pharmacol, 2010, 69(3): 238-244., articleTitle=null, refAbstract=null), Reference(id=1322627036565324088, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=5, authorNames=null, journalName=null, refType=null, unstructuredReference=PICARD M, ROSSIER C, PAPASOULIOTIS O, et al. Bioequivalence of recombinant human FSH and recombinant human LH in a fixed 2: 1 combination: two phase I, randomized, crossover studies[J]. Curr Med Res Opin, 2008, 24(4): 1199-1208., articleTitle=null, refAbstract=null), Reference(id=1322627036661793081, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=6, authorNames=null, journalName=null, refType=null, unstructuredReference=张弨, 翟所迪. 复方雌二醇片在健康绝经妇女体内的生物等效性[J]. 中国临床药理学杂志, 2009, 25(1): 38-43., articleTitle=null, refAbstract=null), Reference(id=1322627036762456378, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=7, authorNames=null, journalName=null, refType=null, unstructuredReference=岳向阳, 金鹏飞, 曹国颖, 等. ICP-MS研究琥珀酸亚铁片剂的人体药动学及生物等效性[J]. 药物分析杂志, 2011, 31(2): 326-329., articleTitle=null, refAbstract=null), Reference(id=1322627036909257019, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=8, authorNames=null, journalName=null, refType=null, unstructuredReference=汤洁, 元唯安, 胡薏慧, 等. 研究型中医院药物临床试验中受试者依从性的影响因素及应对措施[J]. 上海中医药杂志, 2016, (Suppl 1): S80-S83., articleTitle=null, refAbstract=null), Reference(id=1322627037047669052, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[10], rfOrder=9, authorNames=null, journalName=null, refType=null, unstructuredReference=米博, 李艳芬, 孙金霞, 等.Ⅰ期临床试验病房的管理及体会[J]. 天津中医药, 2016, 33(12): 736-739., articleTitle=null, refAbstract=null), Reference(id=1322627037139943741, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[11], rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=Food and Drug Administration. Guidance for industry: potassium chloride modified-relaase tablets and capsules-in vivo Bioequivalence and in vitro dissolution testing[EB/OL]. [2005]. https://www.federalregister.gov/documents/2005/10/26/05-21347/guidance-for-industry-on-potassium-chloride-modified-release-tablets-and-capsules-in-vivo., articleTitle=null, refAbstract=null), Reference(id=1322627037202858302, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=陈修贵, 樊慧蓉, 陈丽珍, 等. 氯化钾缓释片的人体生物等效性研究[J]. 中国药学杂志, 2008, 43(12): 933-936., articleTitle=null, refAbstract=null), Reference(id=1322627037295132991, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[13], rfOrder=12, authorNames=null, journalName=null, refType=null, unstructuredReference=FDA. Draft guidance on potassium citrate[EB/OL]. [2010-08]. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM224224.Pdf., articleTitle=null, refAbstract=null), Reference(id=1322627037379019072, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=13, authorNames=null, journalName=null, refType=null, unstructuredReference=刘倩, 南楠, 李涛, 等. FDA《特定药物的生物等效性指导原则》内源性物质药物生物等效性指导原则介绍[J]. 中国新药杂志, 2018, 27(5): 509-514., articleTitle=null, refAbstract=null), Reference(id=1322627037446127937, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=14, authorNames=null, journalName=null, refType=null, unstructuredReference=BAKER M. Biorepositories: Building better biobanks[J]. Nature, 2012, 486(7401): 141-146., articleTitle=null, refAbstract=null), Reference(id=1322627037517431106, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[16], rfOrder=15, authorNames=null, journalName=null, refType=null, unstructuredReference=朱园园, 王思扬, 任健, 等. 临床试验生物样本的处理与保存规范[J]. 中国药物与临床, 2019, 19(16): 2846-2847., articleTitle=null, refAbstract=null), Reference(id=1322627037597122883, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[17], rfOrder=16, authorNames=null, journalName=null, refType=null, unstructuredReference=US Dept of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry: levothyroxine sodium tablets-in vivo pharmacokinetic and bioavailability studies and in vitro dissolution testing[EB/OL]. [2000-12-01]. http://www.fda.gov/cder/guidance/index.htm., articleTitle=null, refAbstract=null), Reference(id=1322627037655843140, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[18], rfOrder=17, authorNames=null, journalName=null, refType=null, unstructuredReference=JACOBSEN LV, ROLAN P, CHRISTENSEN MS, et al. Bioequivalence between ready-to-use recombinant human growth hormone (rhGH) in liquid formulation and rhGH for reconstitution[J]. Growth Horm IGF Res, 2000, 10(2): 93-98., articleTitle=null, refAbstract=null), Reference(id=1322627037722952005, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[19], rfOrder=18, authorNames=null, journalName=null, refType=null, unstructuredReference=汪旻晖, 江思艳, 胡骅, 等. 生物等效性研究数据管理质量控制体系的建立及应用[J]. 中国新药杂志, 2018, 27(22): 2602-2606., articleTitle=null, refAbstract=null), Reference(id=1322627037790060870, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627032987582728, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[20], rfOrder=19, authorNames=null, journalName=null, refType=null, unstructuredReference=强桂芬, 杨漫, 张娅喃, 等. 对提高人体生物等效性试验安全性策略的探讨[J]. 中国新药杂志, 2011, 20(14): 1261-1265., articleTitle=null, 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