Article(id=1291704911872413824, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.18.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1745856000000, receivedDateStr=2025-04-29, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896049706, onlineDateStr=2026-08-05, pubDate=1758988800000, pubDateStr=2025-09-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896049706, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896049706, creator=13701087609, updateTime=1785896049706, updator=13701087609, issue=Issue{id=1291704811443999077, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='18', pageStart='2551', pageEnd='2700', issueExtLink='null', onlineDate='null', pubDate='1758988800000', pubDateStr='2025-09-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896025763, creator='13701087609', updateTime=1785896871490, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708358743053253, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708358743053254, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704811443999077, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2692, endPage=2696, ext={EN=ArticleExt(id=1291704912115683457, articleId=1291704911872413824, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Considerations in clinical pharmacology research in the development of combination chemical drug, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

The research and development of combination chemical drug occupy an important position in the development of new drugs and generic drugs. Two or more active ingredients are often formulated into combined preparations for development based on clinical needs, the mechanism of drug action and actual clinical effects. In the research and development of combined chemical drugs, clinical pharmacology research serves as a crucial bridge connecting the theories of drug research and development and the practical application in clinical practice. Based on regulations and guidelines, this article explores the application of clinical pharmacology research in the research and development of combined pharmaceutical preparations by integrating research and development cases, clinical practice and literature research.

, authors=Fei-fei LIU, Dong LIU, Dong LI, Yu-zhu WANG, authorsList=Fei-fei LIU, Dong LIU, Dong LI, Yu-zhu WANG, authorCompany=null, correspAuthors=Yu-zhu WANG, 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=1291704912518336642, articleId=1291704911872413824, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=化药复方药物研发中临床药理研究的一般考虑, 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=

化药复方药物的研发在新药和仿制药研发中占据重要的地位。根据临床需要、药物作用机制及实际临床效应常将2种或2种以上活性成份组成复方制剂进行开发。在化药复方药物研发中,临床药理学研究是连接药物研发理论与临床实践应用的关键桥梁。本文根据法规和指导原则,结合研发案例,临床实践和文献调研等探讨临床药理研究在复方药物研发中的应用。

, authors=刘霏霏, 刘冬, 李栋, 王玉珠, authorsList=刘霏霏, 刘冬, 李栋, 王玉珠, authorCompany=null, correspAuthors=王玉珠, authorNote=

刘霏霏(1987-),女,审评员,主要从事临床药理审评工作

, correspAuthorsNote=
王玉珠,研究员 Tel:(010)68585817 E-mail:
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刘霏霏(1987-),女,审评员,主要从事临床药理审评工作

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刘霏霏(1987-),女,审评员,主要从事临床药理审评工作

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化药复方药物研发中临床药理研究的一般考虑
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刘霏霏 , 刘冬 , 李栋 , 王玉珠
中国临床药理学杂志 | 药物评价与管理 2025,41(18): 2692-2696
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中国临床药理学杂志 |药物评价与管理 2025 , 41 (18) : 2692 -2696
化药复方药物研发中临床药理研究的一般考虑
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刘霏霏, 刘冬, 李栋, 王玉珠
作者信息
  • 国家药品监督管理局 药品审评中心,北京 100076
通讯作者:
王玉珠,研究员 Tel:(010)68585817 E-mail:
作者简介:

刘霏霏(1987-),女,审评员,主要从事临床药理审评工作

Considerations in clinical pharmacology research in the development of combination chemical drug
Fei-fei LIU, Dong LIU, Dong LI, Yu-zhu WANG
Affiliations
  • Center of Drug Evaluation, National Medical Products Administration, Beijing 100076, China
出版时间: 2025-09-28 doi: 10.13699/j.cnki.1001-6821.2025.18.021
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化药复方药物的研发在新药和仿制药研发中占据重要的地位。根据临床需要、药物作用机制及实际临床效应常将2种或2种以上活性成份组成复方制剂进行开发。在化药复方药物研发中,临床药理学研究是连接药物研发理论与临床实践应用的关键桥梁。本文根据法规和指导原则,结合研发案例,临床实践和文献调研等探讨临床药理研究在复方药物研发中的应用。

化药复方药物  /  临床药理  /  药物研发  /  试验设计

The research and development of combination chemical drug occupy an important position in the development of new drugs and generic drugs. Two or more active ingredients are often formulated into combined preparations for development based on clinical needs, the mechanism of drug action and actual clinical effects. In the research and development of combined chemical drugs, clinical pharmacology research serves as a crucial bridge connecting the theories of drug research and development and the practical application in clinical practice. Based on regulations and guidelines, this article explores the application of clinical pharmacology research in the research and development of combined pharmaceutical preparations by integrating research and development cases, clinical practice and literature research.

combination chemical drug  /  clinical pharmacology  /  drug research and development  /  study design
刘霏霏, 刘冬, 李栋, 王玉珠. 化药复方药物研发中临床药理研究的一般考虑. 中国临床药理学杂志, 2025 , 41 (18) : 2692 -2696 . DOI: 10.13699/j.cnki.1001-6821.2025.18.021
Fei-fei LIU, Dong LIU, Dong LI, Yu-zhu WANG. Considerations in clinical pharmacology research in the development of combination chemical drug[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (18) : 2692 -2696 . DOI: 10.13699/j.cnki.1001-6821.2025.18.021

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doi: 10.13699/j.cnki.1001-6821.2025.18.021
  • 接收时间:2025-04-29
  • 首发时间:2026-08-05
  • 出版时间:2025-09-28
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  • 收稿日期:2025-04-29
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    国家药品监督管理局 药品审评中心,北京 100076

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王玉珠,研究员 Tel:(010)68585817 E-mail:
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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