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Article(id=1292126500296355970, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.02.023, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1766764800000, receivedDateStr=2025-12-27, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996564219, onlineDateStr=2026-08-06, pubDate=1769529600000, pubDateStr=2026-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996564219, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996564219, creator=13701087609, updateTime=1785996564219, updator=13701087609, issue=Issue{id=1292126409196064779, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1769529600000', pubDateStr='2026-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996542500, creator='13701087609', updateTime=1786014671444, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292202447569707674, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292202447569707675, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=291, endPage=296, ext={EN=ArticleExt(id=1292126500518654083, articleId=1292126500296355970, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Development and application of a core data set for bioequivalence trials based on CDISC standards, columnId=1292126496848638045, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Regulatory Science Column, runingTitle=null, highlight=null, articleAbstract=
Objective

To address issues such as low efficiency and poor consistency in the submission of bioequivalence trial data under the Clinical Data Interchange Standards Consortium standards, this study aimed to develop a set of reusable standardized core data sets to improve data preparation efficiency and regulatory submission quality.

Methods

A systematic review of multiple approved BE trial projects was conducted, covering different trial designs, dosage forms, and study types. Common data structures and mapping rules were extracted through business analysis, and standardized data set templates covering both SDTM and ADaM layers were developed in strict accordance with CDISC standards.

Results

This study summarized 274 SDTM and 338 ADaM data element-specific attributes applicable to bioequivalence trials. A set of standardized core data sets suitable for most BE trial scenarios was established and successfully applied in a two-formulation, two-period, two-sequence crossover BE study evaluating a gel patch.

Conclusion

The standardized dataset constructed in this study provides a preliminary framework for the standardization of BE trial data, which requires further validation through large-scale applications to clarify its applicability and robustness in enhancing the standardization level and work efficiency of BE trial data processing. It holds significant practical value for ensuring data quality and improving the success rate of submissions, while also serving as a referenceable example for the development of foundational datasets within the industry.

, authors=Si-qi WANG1, Zhao-he LI2, Min-guang ZHANG2, Na XIE1, Ya-he ZHU1, Ying WU1, Heng-hui LIU2, authorsList=Si-qi WANG, Zhao-he LI, Min-guang ZHANG, Na XIE, Ya-he ZHU, Ying WU, Heng-hui LIU, authorCompany=null, correspAuthors=Ying WU, Heng-hui 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=1292126500845809796, articleId=1292126500296355970, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=基于CDISC标准的生物等效性试验基本数据集构建与应用, columnId=1292126497112879199, journalTitle=中国临床药理学杂志, columnName=药物监管科学专栏, runingTitle=null, highlight=null, articleAbstract=
目的

为解决生物等效性试验数据在遵循临床数据交换标准协会标准递交过程中存在的效率低、一致性差等问题，构建一套可复用的标准化基本数据集，以提升数据准备效率与监管递交质量。

方法

系统回顾多项已完成BE试验项目，涵盖不同试验设计、剂型及研究类型，通过业务分析提炼共性数据结构与映射规则，并严格依据CDISC标准构建覆盖SDTM与ADaM两层的标准化数据集模板。

结果

本研究共归纳出适用于生物等效性试验的SDTM数据元专用属性274项及ADaM数据元专用属性338项，形成了一套适用于多数BE试验场景的标准化基本数据集，并在一项两制剂、两周期、两交叉评价某凝胶贴膏贴剂的BE研究中成功应用。

结论

本研究所构建的标准化数据集能为BE试验数据标准化提供了初步框架，待进一步大规模应用验证，明确其对提升BE试验数据处理的规范化水平与工作效率的适用性与稳健性。对保障数据质量、提高递交成功率具有重要实践价值，并为行业内的基本数据集构建提供了可借鉴的范例。

, authors=王思琪1, 李钊合2, 张敏广2, 谢娜1, 朱亚河1, 武英1, 刘亨辉2, authorsList=王思琪, 李钊合, 张敏广, 谢娜, 朱亚河, 武英, 刘亨辉, authorCompany=null, correspAuthors=武英, 刘亨辉, authorNote=

王思琪（2000-），女，硕士研究生，主要从事数据标准化相关研究

, correspAuthorsNote=
武英，副教授，研究生导师 MP: 15133915086 E-mail:
刘亨辉 MP: 18618242428 E-mail:
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王思琪（2000-），女，硕士研究生，主要从事数据标准化相关研究

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王思琪（2000-），女，硕士研究生，主要从事数据标准化相关研究

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基于CDISC标准的生物等效性试验基本数据集构建与应用
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王思琪 1 , 李钊合 2 , 张敏广 2 , 谢娜 1 , 朱亚河 1 , 武英 1 , 刘亨辉 2
中国临床药理学杂志 | 药物监管科学专栏 2026,42(2): 291-296
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中国临床药理学杂志 |药物监管科学专栏 2026 , 42 (2) : 291 -296
基于CDISC标准的生物等效性试验基本数据集构建与应用
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王思琪1, 李钊合2, 张敏广2, 谢娜1, 朱亚河1, 武英1 , 刘亨辉2
作者信息
  • 1.华北理工大学 公共卫生学院，河北 唐山 063210
  • 2.北京裕荣医学数据科技有限公司，北京 100176
通讯作者:
武英，副教授，研究生导师 MP: 15133915086 E-mail:
刘亨辉 MP: 18618242428 E-mail:
作者简介:

王思琪（2000-），女，硕士研究生，主要从事数据标准化相关研究

Development and application of a core data set for bioequivalence trials based on CDISC standards
Si-qi WANG1, Zhao-he LI2, Min-guang ZHANG2, Na XIE1, Ya-he ZHU1, Ying WU1 , Heng-hui LIU2
Affiliations
  • 1.School of Public Health, North China University of Science and Technology, Tangshan 063210, Hebei Province, China
  • 2.Beijing Yurong Medical Data Technology Co., Ltd., Beijing 100176, China
出版时间: 2026-01-28 doi: 10.13699/j.cnki.1001-6821.2026.02.023
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摘要
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目的

为解决生物等效性试验数据在遵循临床数据交换标准协会标准递交过程中存在的效率低、一致性差等问题，构建一套可复用的标准化基本数据集，以提升数据准备效率与监管递交质量。

方法

系统回顾多项已完成BE试验项目，涵盖不同试验设计、剂型及研究类型，通过业务分析提炼共性数据结构与映射规则，并严格依据CDISC标准构建覆盖SDTM与ADaM两层的标准化数据集模板。

结果

本研究共归纳出适用于生物等效性试验的SDTM数据元专用属性274项及ADaM数据元专用属性338项，形成了一套适用于多数BE试验场景的标准化基本数据集，并在一项两制剂、两周期、两交叉评价某凝胶贴膏贴剂的BE研究中成功应用。

结论

本研究所构建的标准化数据集能为BE试验数据标准化提供了初步框架，待进一步大规模应用验证，明确其对提升BE试验数据处理的规范化水平与工作效率的适用性与稳健性。对保障数据质量、提高递交成功率具有重要实践价值，并为行业内的基本数据集构建提供了可借鉴的范例。

临床数据交换标准协会  /  生物等效性试验  /  基本数据集  /  研究数据制表模型  /  分析数据模型  /  数据融合
Objective

To address issues such as low efficiency and poor consistency in the submission of bioequivalence trial data under the Clinical Data Interchange Standards Consortium standards, this study aimed to develop a set of reusable standardized core data sets to improve data preparation efficiency and regulatory submission quality.

Methods

A systematic review of multiple approved BE trial projects was conducted, covering different trial designs, dosage forms, and study types. Common data structures and mapping rules were extracted through business analysis, and standardized data set templates covering both SDTM and ADaM layers were developed in strict accordance with CDISC standards.

Results

This study summarized 274 SDTM and 338 ADaM data element-specific attributes applicable to bioequivalence trials. A set of standardized core data sets suitable for most BE trial scenarios was established and successfully applied in a two-formulation, two-period, two-sequence crossover BE study evaluating a gel patch.

Conclusion

The standardized dataset constructed in this study provides a preliminary framework for the standardization of BE trial data, which requires further validation through large-scale applications to clarify its applicability and robustness in enhancing the standardization level and work efficiency of BE trial data processing. It holds significant practical value for ensuring data quality and improving the success rate of submissions, while also serving as a referenceable example for the development of foundational datasets within the industry.

CDISC  /  bioequivalence trial  /  core data set  /  SDTM  /  ADaM  /  data harmonization
王思琪, 李钊合, 张敏广, 谢娜, 朱亚河, 武英, 刘亨辉. 基于CDISC标准的生物等效性试验基本数据集构建与应用. 中国临床药理学杂志, 2026 , 42 (2) : 291 -296 . DOI: 10.13699/j.cnki.1001-6821.2026.02.023
Si-qi WANG, Zhao-he LI, Min-guang ZHANG, Na XIE, Ya-he ZHU, Ying WU, Heng-hui LIU. Development and application of a core data set for bioequivalence trials based on CDISC standards[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (2) : 291 -296 . DOI: 10.13699/j.cnki.1001-6821.2026.02.023

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doi: 10.13699/j.cnki.1001-6821.2026.02.023
  • 接收时间：2025-12-27
  • 首发时间：2026-08-06
  • 出版时间：2026-01-28
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  • 收稿日期：2025-12-27
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作者信息
    1.华北理工大学 公共卫生学院，河北 唐山 063210
    2.北京裕荣医学数据科技有限公司，北京 100176

通讯作者:

武英，副教授，研究生导师 MP: 15133915086 E-mail:
刘亨辉 MP: 18618242428 E-mail:
参考文献
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.02.023
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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