中国基于模型的药物研发现状与挑战

IF 15.2 1区 医学 Q1 PHARMACOLOGY & PHARMACY Advanced drug delivery reviews Pub Date : 2024-10-09 DOI:10.1016/j.addr.2024.115459
Yuzhu Wang , Jia Ji , Ye Yao , Jing Nie , Fengbo Xie , Yehua Xie , Gailing Li
{"title":"中国基于模型的药物研发现状与挑战","authors":"Yuzhu Wang ,&nbsp;Jia Ji ,&nbsp;Ye Yao ,&nbsp;Jing Nie ,&nbsp;Fengbo Xie ,&nbsp;Yehua Xie ,&nbsp;Gailing Li","doi":"10.1016/j.addr.2024.115459","DOIUrl":null,"url":null,"abstract":"<div><div>In the past decade, biopharmaceutical research and development in China has been notably boosted by government policies, regulatory initiatives and increasing investments in life sciences. With regulatory agency acting as a strong driver, model-informed drug development (MIDD) is transitioning rapidly from an academic pursuit to a critical component of innovative drug discovery and development within the country. In this article, we provided a cross-sectional summary on the current status of MIDD implementations across early and late-stage drug development in China, illustrated by case examples. We also shared insights into regulatory policy development and decision-making. Various modeling and simulation approaches were presented across a range of applications. Furthermore, the challenges and opportunities of MIDD in China were discussed and compared with other regions where these practices have a more established history. Through this analysis, we highlighted the potential of MIDD to enhance drug development efficiency and effectiveness in China’s evolving pharmaceutical landscape.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"214 ","pages":"Article 115459"},"PeriodicalIF":15.2000,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Current status and challenges of model-informed drug discovery and development in China\",\"authors\":\"Yuzhu Wang ,&nbsp;Jia Ji ,&nbsp;Ye Yao ,&nbsp;Jing Nie ,&nbsp;Fengbo Xie ,&nbsp;Yehua Xie ,&nbsp;Gailing Li\",\"doi\":\"10.1016/j.addr.2024.115459\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><div>In the past decade, biopharmaceutical research and development in China has been notably boosted by government policies, regulatory initiatives and increasing investments in life sciences. With regulatory agency acting as a strong driver, model-informed drug development (MIDD) is transitioning rapidly from an academic pursuit to a critical component of innovative drug discovery and development within the country. In this article, we provided a cross-sectional summary on the current status of MIDD implementations across early and late-stage drug development in China, illustrated by case examples. We also shared insights into regulatory policy development and decision-making. Various modeling and simulation approaches were presented across a range of applications. Furthermore, the challenges and opportunities of MIDD in China were discussed and compared with other regions where these practices have a more established history. Through this analysis, we highlighted the potential of MIDD to enhance drug development efficiency and effectiveness in China’s evolving pharmaceutical landscape.</div></div>\",\"PeriodicalId\":7254,\"journal\":{\"name\":\"Advanced drug delivery reviews\",\"volume\":\"214 \",\"pages\":\"Article 115459\"},\"PeriodicalIF\":15.2000,\"publicationDate\":\"2024-10-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advanced drug delivery reviews\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0169409X24002813\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advanced drug delivery reviews","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0169409X24002813","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

摘要

在过去的十年中,政府政策、监管措施以及对生命科学投资的不断增加显著推动了中国的生物制药研发。在监管机构的大力推动下,模型信息药物开发(MIDD)正从学术研究迅速转变为国内创新药物研发的重要组成部分。在这篇文章中,我们通过案例对中国药物研发早期和晚期阶段的 MIDD 实施现状进行了横向总结。我们还分享了对监管政策制定和决策的见解。我们还介绍了各种应用领域的建模和模拟方法。此外,我们还讨论了 MIDD 在中国面临的挑战和机遇,并将其与其他地区进行了比较。通过这些分析,我们强调了 MIDD 在中国不断变化的制药环境中提高药物开发效率和有效性的潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

摘要图片

摘要图片

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Current status and challenges of model-informed drug discovery and development in China
In the past decade, biopharmaceutical research and development in China has been notably boosted by government policies, regulatory initiatives and increasing investments in life sciences. With regulatory agency acting as a strong driver, model-informed drug development (MIDD) is transitioning rapidly from an academic pursuit to a critical component of innovative drug discovery and development within the country. In this article, we provided a cross-sectional summary on the current status of MIDD implementations across early and late-stage drug development in China, illustrated by case examples. We also shared insights into regulatory policy development and decision-making. Various modeling and simulation approaches were presented across a range of applications. Furthermore, the challenges and opportunities of MIDD in China were discussed and compared with other regions where these practices have a more established history. Through this analysis, we highlighted the potential of MIDD to enhance drug development efficiency and effectiveness in China’s evolving pharmaceutical landscape.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
28.10
自引率
5.00%
发文量
294
审稿时长
15.1 weeks
期刊介绍: The aim of the Journal is to provide a forum for the critical analysis of advanced drug and gene delivery systems and their applications in human and veterinary medicine. The Journal has a broad scope, covering the key issues for effective drug and gene delivery, from administration to site-specific delivery. In general, the Journal publishes review articles in a Theme Issue format. Each Theme Issue provides a comprehensive and critical examination of current and emerging research on the design and development of advanced drug and gene delivery systems and their application to experimental and clinical therapeutics. The goal is to illustrate the pivotal role of a multidisciplinary approach to modern drug delivery, encompassing the application of sound biological and physicochemical principles to the engineering of drug delivery systems to meet the therapeutic need at hand. Importantly the Editorial Team of ADDR asks that the authors effectively window the extensive volume of literature, pick the important contributions and explain their importance, produce a forward looking identification of the challenges facing the field and produce a Conclusions section with expert recommendations to address the issues.
期刊最新文献
Seeing through the skin: Optical methods for visualizing transdermal drug delivery with microneedles 3D printing of drug delivery systems enhanced with micro/nano-technology Integrated pharmacokinetic-pharmacodynamic and agent-based modelling in drug development: Current status and future perspectives Integrated modeling of biomarkers, survival and safety in clinical oncology drug development Chaotic (bio)printing in the context of drug delivery systems
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1