Article(id=1236330551049778143, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236330549866975405, 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=1692028800000, acceptedDateStr=2023-08-15, onlineDate=1772693773280, onlineDateStr=2026-03-05, pubDate=1697299200000, pubDateStr=2023-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772693773280, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772693773280, creator=13701087609, updateTime=1772693773280, updator=13701087609, issue=Issue{id=1236330549866975405, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='19', pageStart='1905', pageEnd='2008', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772693772998, creator=13701087609, updateTime=1772695059296, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236335945046348400, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236330549866975405, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236335945046348401, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236330549866975405, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1915, endPage=1922, ext={EN=ArticleExt(id=1236330551267881953, articleId=1236330551049778143, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Special technical considerations for clinical development and evaluation of locally applied locally acting drugs, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: Focusing on the specialty of locally applied locally acting drugs, we discuss and explain the special considerations in its design and evaluation of clinical trials.
Methods: The technical guidelines on the research and development of locally applied locally acting drugs issued by domestic and foreign regulatory agencies and related literature were extensively investigated. The relevant drug research and development situation and review practice were combed. Combined with case analysis and expert discussion opinions, the technical standards for clinical research and development of local drugs under different registration types were discussed.
Results & Conclusion: The sponsor should formulate the corresponding research and development strategy based on the clinical medication needs and developmental background. For the innovative drugs, in addition to following the general consideration of clinical trials of innovative drugs, specific studies should also be carried out at the same time considering the characteristics of drug dosage forms, the routes of administration, and application sites, etc. Meanwhile, due to the technical and ethical difficulties of sampling in local pharmacokinetics and pharmacodynamics research, pharmaceutical quality research and comprehensive non-clinical research are particularly important. Some necessary exploratory and confirmatory clinical trials should be carried out combining the clinical data of the original active ingredient to prove the clinical advantages in safety and effectiveness etc. of the improved drug. For generic drugs that is locally administered and locally acting, beside pharmacy and non-clinical comparative studies with the original reference preparations, the sponsors may also need to carry out necessary human pharmacokinetics, pharmacodynamics, and even clinical equivalence trials to prove the consistency of quality and efficacy of generic drugs and reference preparations.
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目的： 针对局部给药局部起效药物的特殊性，探讨并阐释其临床试验设计和评价的特殊考虑。
方法： 在广泛调研国内外监管机构发布的局部给药局部起效药物研发技术指导原则及相关文献、梳理相关药物研发情况和审评实践的基础上，结合案例分析和专家研讨意见，探讨了不同注册类型下局部药物临床研发的技术标准。
结果与结论： 申请人应基于药物临床需求和研发背景，制定相应的研发策略。对于创新药，除遵循创新药开展临床试验的一般考虑外，还应结合药物的剂型特点、给药途径、应用部位等，开展特定的研究。同时因局部药动学、药效学研究存在采样等技术难度或伦理问题，药学质量研究和全面的非临床研究尤为重要；改良型新药需结合改良前同活性成分药物的临床数据基础，开展必要的探索性和确证性试验，以证明改良型新药具有安全性和有效性等临床优势；局部给药局部起效的仿制药，则需在与原研参比制剂进行药学、非临床方面充分对比研究的基础上，考虑开展必要的人体药动学、药效学甚至临床等效性对比试验等，证明仿制药与参比制剂质量和疗效的一致性。
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, authorsList=赵聪, 钱思源, 葛玉梅, 杨靖怡, 翟云, 韵文萍, 谢松梅)}, authors=[Author(id=1236330551863473136, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236330551049778143, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=zhaoc@cde.org.cn, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236330552018662388, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236330551049778143, authorId=1236330551863473136, language=EN, stringName=Cong ZHAO, firstName=Cong, middleName=null, lastName=ZHAO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236330552102548471, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236330551049778143, authorId=1236330551863473136, language=CN, stringName=赵聪, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=null, address=国家药品监督管理局药品审评中心，北京 100022, bio={"content":"
赵聪，女，医学硕士，助理研究员，研究方向：新药技术审评。E-mail: zhaoc@cde.org.cn。
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赵聪，女，医学硕士，助理研究员，研究方向：新药技术审评。E-mail: zhaoc@cde.org.cn。
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