Formerly (retired) National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Drug Deliv Transl Res. 2022 Sep;12(9):2042-2047. doi: 10.1007/s13346-022-01208-4. Epub 2022 Jul 30.
Nanotechnologies enable great opportunities for the development and use of innovative (nano)medicines. As is common for scientific and technical developments, recognized safety evaluation methods for regulatory purposes are lagging behind. The specific properties responsible for the desired functioning also hamper the safety evaluation of such products. Pharmacokinetics determination of the active pharmaceutical ingredient as well as the nanomaterial component is crucial. Due to their particulate nature, nanomedicines, similar to all nanomaterials, are primarily removed from the circulation by phagocytizing cells that are part of the immune system. Therefore, the immune system can be potentially a specific target for adverse effects of nanomedicines, and thus needs special attention during the safety evaluation. This DDTR special issue on the results of the REFINE project on a regulatory science framework for nanomedical products presents a highly valuable body of knowledge needed to address regulatory challenges and gaps in currently available testing methods for the safety evaluation of nanomedicines.
纳米技术为开发和使用创新的（纳米）药物带来了巨大的机遇。与科学和技术发展一样，为监管目的而认可的安全评估方法也存在滞后。负责预期功能的特定特性也妨碍了此类产品的安全评估。确定活性药物成分和纳米材料成分的药代动力学是至关重要的。由于它们的颗粒性质，纳米药物与所有纳米材料一样，主要通过作为免疫系统一部分的吞噬细胞从循环中清除。因此，免疫系统可能是纳米药物产生不良反应的特定靶标，因此在安全评估过程中需要特别注意。本关于纳米医学产品监管科学框架 REFINE 项目结果的 DDTR 特刊提供了大量有价值的知识，这些知识是解决当前纳米药物安全评估测试方法中存在的监管挑战和差距所必需的。
