Bernard J. Dunn School of Pharmacy, Shenandoah University, Winchester, VA 22601, USA.
School of Pharmacy, University of Missouri-Kansas City, Kansas City, MO 64108, USA; Present address: CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA.
Drug Discov Today. 2018 May;23(5):974-991. doi: 10.1016/j.drudis.2018.01.047. Epub 2018 Jan 31.
There are numerous hurdles hindering the clinical translation of nanomedicines. The major challenges are: reproducible manufacturing and scale-up, availability of appropriate characterization methods, instability under in vivo environments, safety issues, poor understanding of the disease heterogeneity and patient preselection strategies, regulatory barriers and inadequate understanding of the biophysical and chemical interactions of nanoformulations. Thus, a better understanding of key physicochemical attributes and their characterization methods, in vivo behavior and the in-vitro-in-vivo characterization cascade of stability, safety and efficacy testing is needed to accelerate nanomedicine translation. Technologies such as quality-by-design, process analytical techniques and microfluidics could significantly accelerate the translation of nanomedicines. However, these approaches require further learning and an adequate regulatory background. Overall, to achieve an efficient clinical translation, collaboration among academia, industry and regulatory bodies is required to ensure safe and effective nanomedicine products. This review discusses the challenges and opportunities to facilitate the translation of nanomedicines to a commercial product.
有许多障碍阻碍了纳米医学的临床转化。主要挑战是：可重复的制造和放大、适当的表征方法的可用性、体内环境下的不稳定性、安全性问题、对疾病异质性和患者预选策略的理解不足、监管障碍以及对纳米制剂的生物物理和化学相互作用的理解不足。因此，需要更好地了解关键物理化学特性及其表征方法、体内行为以及稳定性、安全性和功效测试的体外-体内表征级联，以加速纳米医学的转化。质量源于设计、过程分析技术和微流控等技术可以显著加速纳米药物的转化。然而，这些方法需要进一步的学习和足够的监管背景。总的来说，要实现有效的临床转化，需要学术界、工业界和监管机构之间的合作，以确保安全有效的纳米医学产品。本综述讨论了促进纳米医学转化为商业产品的挑战和机遇。
