Challenges in nanomedicine clinical translation
Challenges in nanomedicine clinical translation
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DOI：
10.1007/s13346-020-00740-5
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发表时间：
2020-06-01
影响因子：
5.4
通讯作者：
Lammers, Twan
中科院分区：
文献类型：
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作者：
Metselaar, Josbert M.;Lammers, Twan
新的纳米药物配方和纳米药物的新应用几乎每天都有报道。虽然学术进步和社会承诺继续瞄准明星，但工业接受度和临床翻译正受到越来越多的批评。我们在这里讨论了在促进纳米药物临床转化时需要考虑的五个关键挑战。我们从终端用户的角度出发，以自上而下的方式解决发展路径。我们从解决与实践和临床可行性相关的核心和更一般的问题开始，然后是纳米药物产品开发所需的更具体的临床前、临床和制药方面。我们相信，在纳米医学发展的早期阶段，更多地了解终端用户的观点将有助于更好地监督所需的努力和投资，并在市场机会、目标疾病适应症、临床试验设计、治疗终点、临床前模型和配方规范方面做出最佳决策。对纳米药物翻译过程的批判性思考和周密的路线规划有助于促进纳米药物的成功。图形抽象
New 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.Graphical abstract