Sivasubramanian Maharajan, Lin Li-Jie, Wang Yu-Chao, Yang Chung-Shi, Lo Leu-Wei
Institute of Biomedical Engineering and Nanomedicine, National Health Research Institutes, Zhunan, Taiwan.
Front Chem. 2022 Aug 19;10:918715. doi: 10.3389/fchem.2022.918715. eCollection 2022.
The emergence of nanomedicines (NMs) in the healthcare industry will bring about groundbreaking improvements to the current therapeutic and diagnostic scenario. However, only a few NMs have been developed into clinical applications due to a lack of regulatory experience with them. In this article, we introduce the types of NM that have the potential for clinical translation, including theranostics, multistep NMs, multitherapy NMs, and nanoclusters. We then present the clinical translational challenges associated with NM from the pharmaceutical industry's perspective, such as NMs' intrinsic physiochemical properties, safety, scale-up, lack of regulatory experience and standard characterization methods, and cost-effectiveness compared with their traditional counterparts. Overall, NMs face a difficult task to overcome these challenges for their transition from bench to clinical use.
纳米药物（NMs）在医疗保健行业的出现将给当前的治疗和诊断状况带来突破性的改善。然而，由于缺乏对它们的监管经验，只有少数纳米药物已被开发用于临床应用。在本文中，我们介绍了具有临床转化潜力的纳米药物类型，包括诊疗一体化纳米药物、多步纳米药物、多疗法纳米药物和纳米团簇。然后，我们从制药行业的角度阐述了与纳米药物相关的临床转化挑战，例如纳米药物的固有物理化学性质、安全性、放大生产、缺乏监管经验和标准表征方法，以及与传统同类药物相比的成本效益。总体而言，纳米药物要克服这些挑战从实验室走向临床应用面临艰巨任务。
