纳米颗粒治疗的临床前景:分类,上市产品和监管前景

IF 13 2区 材料科学 Q1 CHEMISTRY, MULTIDISCIPLINARY
Small Pub Date : 2025-06-02 DOI:10.1002/smll.202502315
Nimeet Desai, Dhwani Rana, Mitali Patel, Neha Bajwa, Rajendra Prasad, Lalitkumar K. Vora
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引用次数: 0

摘要

基于纳米粒子的治疗方法源于纳米技术的进步,由于其独特的生物特性而优于传统的药物治疗方法,这些特性增强了治疗效果,降低了毒性,并实现了精确的靶向。自20世纪80年代以来,基于纳米颗粒的药物产品的数量大大增加,占据了药品市场的很大一部分。这些系统的功能是作为治疗剂或载体,将活性药物或诊断化合物输送到目标区域。然而,尽管纳米药物具有变革潜力,但开发全面和协调的纳米药物管理框架仍然是一个重大挑战。这篇综述提供了目前市场批准的纳米颗粒疗法的概述,分析了全球监管策略,包括临床前测试、安全评估、制造过程和质量控制标准。通过讨论现有的不足,这篇综述强调了适应性调控途径在全球背景下的重要性。它旨在支持研究人员和利益相关者在监管环境中导航,促进基于纳米颗粒的治疗方法的成功商业化和临床转化。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape

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.
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来源期刊
Small
Small 工程技术-材料科学:综合
CiteScore
17.70
自引率
3.80%
发文量
1830
审稿时长
2.1 months
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.
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