Author:
Metselaar Josbert M.,Lammers Twan
Abstract
AbstractNew nanomedicine formulations and novel applications of nanomedicinal drugs are reported on an almost daily basis. While academic progress and societal promise continue to shoot for the stars, industrial acceptance and clinical translation are being looked at increasingly critically. We here discuss five key challenges that need to be considered when aiming to promote the clinical translation of nanomedicines. We take the perspective of the end-stage users and consequently address the developmental path in a top-down manner. We start off by addressing central and more general issues related to practical and clinical feasibility, followed by more specific preclinical, clinical, and pharmaceutical aspects that nanomedicinal product development entails. We believe that being more aware of the end user’s perspective already early on in the nanomedicine development path will help to better oversee the efforts and investments needed, and to take optimally informed decisions with regard to market opportunities, target disease indication, clinical trial design, therapeutic endpoints, preclinical models, and formulation specifications. Critical reflections on and careful route planning in nanomedicine translation will help to promote the success of nanomedicinal drugs.
Funder
H2020 European Research Council
Publisher
Springer Science and Business Media LLC
Reference11 articles.
1. Wagner V, Dullaart A, Bock AK, Zweck A. The emerging nanomedicine landscape. Nat Biotechnol. 2006;24:1211–7.
2. Kim BY, Rutka JT, Chan WC. Nanomedicine. N Engl J Med. 2010;363:2434–43.
3. Duncan R, Gaspar R. Nanomedicine(s) under the microscope. Mol Pharm. 2011;8:2101–41.
4. Bobo D, Robinson KJ, Islam J, Thurecht KJ, Corrie SR. Nanoparticle-based medicines: a review of FDA-approved materials and clinical trials to date. Pharm Res. 2016;33:2373–87.
5. D’Mello SR, Cruz CN, Chen ML, Kapoor M, Lee SL, Tyner KM. The evolving landscape of drug products containing nanomaterials in the United States.
Cited by
143 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献