School of Health Sciences, Department of Pharmacy, Laboratory of Pharmaceutical Technology, Section of Pharmaceutical Nanotechnology, National and Kapodistrian University of Athens, Panepistimiopolis Zografou, 15775, Athens, Greece.
IESL, FORTH, Crete, Greece.
AAPS PharmSciTech. 2020 Jan 13;21(2):65. doi: 10.1208/s12249-019-1573-y.
The application of the nanotechnology in medicine and pharmaceutics opens new horizons in therapeutics. Several nanomedicines are in the market and an increasing number is in clinical trials. But which is the advantage of the medicines in nanoscale? The scientists and the regulatory authorities agree that the size and consequently the physiochemical/biological properties of nanomaterials play a key role in their safety and effectiveness. Additionally, all of them agree that a new scientific-based regulatory landscape is required for the establishment of nanomedicines in the market. The aim of this review is to investigate the parameters that the scientists and the regulatory authorities should take into account in order to build up a dynamic regulatory landscape for nanomedicines. For this reason, we propose an "astrolabe-like system" as the guide for establishing the regulatory approval process. Its function is based on the different physicochemical/biological properties in comparison to low molecular weight drugs.
纳米技术在医学和药剂学中的应用为治疗开辟了新的前景。有几种纳米药物已经上市，越来越多的药物正在临床试验中。但是纳米级药物的优势是什么呢？科学家和监管机构都认为，纳米材料的大小以及由此产生的物理化学/生物学特性在其安全性和有效性方面起着关键作用。此外，他们都认为，需要建立一个基于科学的新监管框架，才能将纳米药物推向市场。本综述的目的是研究科学家和监管机构应该考虑的参数，以建立一个动态的纳米药物监管框架。为此，我们提出了一个“星盘状系统”作为建立监管审批程序的指南。它的功能基于与低分子量药物相比的不同物理化学/生物学特性。
