Facilitating the translation of nanomedicines to a clinical product: challenges and opportunities.

Facilitating the translation of nanomedicines to a clinical product: challenges and opportunities. Drug Discov Today. 2018 Jan 31;: Authors: Agrahari V, Agrahari V Abstract 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. 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 nanomedicines. This review discusses the current challenges and opportunities to facilitate the translation of nanomedicines to a commercial product. PMID: 29406263 [PubMed - as supplied by publisher]
Source: Drug Discovery Today - Category: Drugs & Pharmacology Authors: Tags: Drug Discov Today Source Type: research