{"title":"纳米颗粒治疗的临床前景:分类,上市产品和监管前景","authors":"Nimeet Desai, Dhwani Rana, Mitali Patel, Neha Bajwa, Rajendra Prasad, Lalitkumar K. Vora","doi":"10.1002/smll.202502315","DOIUrl":null,"url":null,"abstract":"Nanoparticle-based therapeutics, emerging from advances in nanotechnology, outperform traditional drug therapies by virtue of their distinct biological properties that enhance therapeutic efficacy, reduce toxicity, and enable precise targeting. Since the 1980s, the number of nanoparticle-based pharmaceutical products has expanded considerably, capturing a significant portion of the pharmaceutical market. These systems function as therapeutic agents or as vehicles for delivering active pharmaceutical or diagnostic compounds to targeted areas. However, despite their transformative potential, the development of comprehensive and harmonized regulatory frameworks for nanomedicines remains a critical challenge. This review provides a current overview of market-approved nanoparticle therapeutics, analyzing global regulatory strategies, including pre-clinical testing, safety assessments, manufacturing processes, and quality control standards. By discussing the existing shortcomings, this review highlights the importance of adaptive regulatory pathways in a global context. It aims to support researchers and stakeholders in navigating the regulatory landscape, facilitating the successful commercialization and clinical translation of nanoparticle-based therapeutics.","PeriodicalId":228,"journal":{"name":"Small","volume":"11 1","pages":""},"PeriodicalIF":13.0000,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape\",\"authors\":\"Nimeet Desai, Dhwani Rana, Mitali Patel, Neha Bajwa, Rajendra Prasad, Lalitkumar K. Vora\",\"doi\":\"10.1002/smll.202502315\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Nanoparticle-based therapeutics, emerging from advances in nanotechnology, outperform traditional drug therapies by virtue of their distinct biological properties that enhance therapeutic efficacy, reduce toxicity, and enable precise targeting. Since the 1980s, the number of nanoparticle-based pharmaceutical products has expanded considerably, capturing a significant portion of the pharmaceutical market. These systems function as therapeutic agents or as vehicles for delivering active pharmaceutical or diagnostic compounds to targeted areas. However, despite their transformative potential, the development of comprehensive and harmonized regulatory frameworks for nanomedicines remains a critical challenge. This review provides a current overview of market-approved nanoparticle therapeutics, analyzing global regulatory strategies, including pre-clinical testing, safety assessments, manufacturing processes, and quality control standards. By discussing the existing shortcomings, this review highlights the importance of adaptive regulatory pathways in a global context. It aims to support researchers and stakeholders in navigating the regulatory landscape, facilitating the successful commercialization and clinical translation of nanoparticle-based therapeutics.\",\"PeriodicalId\":228,\"journal\":{\"name\":\"Small\",\"volume\":\"11 1\",\"pages\":\"\"},\"PeriodicalIF\":13.0000,\"publicationDate\":\"2025-06-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Small\",\"FirstCategoryId\":\"88\",\"ListUrlMain\":\"https://doi.org/10.1002/smll.202502315\",\"RegionNum\":2,\"RegionCategory\":\"材料科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MULTIDISCIPLINARY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Small","FirstCategoryId":"88","ListUrlMain":"https://doi.org/10.1002/smll.202502315","RegionNum":2,"RegionCategory":"材料科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}
Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape
Nanoparticle-based therapeutics, emerging from advances in nanotechnology, outperform traditional drug therapies by virtue of their distinct biological properties that enhance therapeutic efficacy, reduce toxicity, and enable precise targeting. Since the 1980s, the number of nanoparticle-based pharmaceutical products has expanded considerably, capturing a significant portion of the pharmaceutical market. These systems function as therapeutic agents or as vehicles for delivering active pharmaceutical or diagnostic compounds to targeted areas. However, despite their transformative potential, the development of comprehensive and harmonized regulatory frameworks for nanomedicines remains a critical challenge. This review provides a current overview of market-approved nanoparticle therapeutics, analyzing global regulatory strategies, including pre-clinical testing, safety assessments, manufacturing processes, and quality control standards. By discussing the existing shortcomings, this review highlights the importance of adaptive regulatory pathways in a global context. It aims to support researchers and stakeholders in navigating the regulatory landscape, facilitating the successful commercialization and clinical translation of nanoparticle-based therapeutics.
期刊介绍:
Small serves as an exceptional platform for both experimental and theoretical studies in fundamental and applied interdisciplinary research at the nano- and microscale. The journal offers a compelling mix of peer-reviewed Research Articles, Reviews, Perspectives, and Comments.
With a remarkable 2022 Journal Impact Factor of 13.3 (Journal Citation Reports from Clarivate Analytics, 2023), Small remains among the top multidisciplinary journals, covering a wide range of topics at the interface of materials science, chemistry, physics, engineering, medicine, and biology.
Small's readership includes biochemists, biologists, biomedical scientists, chemists, engineers, information technologists, materials scientists, physicists, and theoreticians alike.