摘要
将纳米药物从实验室水平转化为上市产品面临着若干挑战,包括物理化学特性的表征、药效学、药代动力学、过程控制、生物相容性和纳米毒性、放大以及可重复性。纳米医学发展的挑战与患者(临床和治疗用途)、工业(生产)和监管机构(授权过程)的不同要求有关。本文旨在回顾基于纳米药物输送系统的现状和监管方面,重点关注食品和药物管理局 (FDA) 和欧洲医药管理局 (EMA) 的法规。除了讨论纳米医学发展所伴随的风险之外,这里还强调了在研发阶段的早期遵循基于风险的方法的潜力,以确保开发新型纳米剂型时的安全性和有效性。纳米药物的研发是一个复杂的、多学科的方法,其监管和立法仍然存在许多挑战。一般来说,纳米药物最关键的考虑因素是产品质量评估(理化特性、质量控制、制造过程)和产品安全评估(药代动力学、生物降解、积累和纳米毒性)。该论文提出了纳米药物开发和营销授权的一个有前途的范例,即质量源于设计 (QbD) 方法。对纳米药物的质量、安全性和有效性有足够的了解是必要的,以便重点关注建立用于评估纳米药物关键质量属性的稳健、标准化的方法。监管机构强烈推荐和要求基于 QbD 的提交,从而实现新型纳米药物的顺利临床转化。
关键词: 欧洲药品管理局 (EMA)、食品和药物管理局 (FDA)、纳米医学、纳米毒性、设计质量 (QbD)、风险评估 (RA)、药物开发。
Current Medicinal Chemistry
Title:Regulatory Considerations, Challenges and Risk-based Approach in Nanomedicine Development
Volume: 28 Issue: 36
关键词: 欧洲药品管理局 (EMA)、食品和药物管理局 (FDA)、纳米医学、纳米毒性、设计质量 (QbD)、风险评估 (RA)、药物开发。
摘要: The translation of nanomedicines from the lab level into marketed product faces several challenges, including characterization of physicochemical properties, pharmacodynamics, pharmacokinetics, process control, biocompatibility, and nanotoxicity, scaling-up as well as reproducibility. The challenges of nanomedicine development are in connection with the different requirements from the patient (clinical and therapeutic use), industry (production), and regulatory bodies (authorization process). This paper aims at reviewing the status and regulatory aspects of nano-based drug delivery systems with a focus on the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) regulations. In addition to discussing the risks accompanied by the development of nanomedicine, the potential of following a risk-based methodology from the early stage of the R&D phase is emphasized here to ensure safety and efficacy when developing novel nano-based dosage forms. The R&D of nanomedicines is a complex and multidisciplinary approach, and there are still many challenges in their regulation and legislation. In general, the most critical considerations for nanomedicines are the product quality assessment (physicochemical characteristics, quality control, manufacturing process) and product safety assessment (pharmacokinetics, biodegradation, accumulation, and nanotoxicity). The paper presents a promising paradigm in the development and marketing authorization of nanomedicines, namely the Quality by Design (QbD) approach. Sufficient knowledge on the quality, safety, and efficacy of nanomedicines is necessary to obtain a significant focus on establishing robust, standardized methods for evaluating the critical quality attributes of nanomedicines. The QbD-based submission is highly recommended and required by the regulatory authorities, enabling a smooth clinical translation of the novel nanomedicines.
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Cite this article as:
Regulatory Considerations, Challenges and Risk-based Approach in Nanomedicine Development, Current Medicinal Chemistry 2021; 28 (36) . https://dx.doi.org/10.2174/0929867328666210406115529
DOI https://dx.doi.org/10.2174/0929867328666210406115529 |
Print ISSN 0929-8673 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-533X |
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