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Active ingredient vs excipient debate for nanomedicines
Nature Nanotechnology ( IF 38.1 ) Pub Date : 2023-04-27 , DOI: 10.1038/s41565-023-01371-w
Eva Hemmrich 1 , Scott McNeil 1
Affiliation  

Nanomedicines are complex drugs where components that have typically been regarded as excipients may now be considered part of the active ingredient. The distinction between the active ingredient and excipients for nanomedicines has important consequences for regulatory review and product development. The dissimilarity in the review of the recent ribonucleic acid (RNA)-based lipid nanoparticles highlights the need for further regulatory alignment on this topic.

中文翻译:


纳米药物活性成分与赋形剂的争论



纳米药物是复杂的药物,其中通常被视为赋形剂的成分现在可能被视为活性成分的一部分。纳米药物活性成分和赋形剂之间的区别对于监管审查和产品开发具有重要影响。最近对基于核糖核酸(RNA)的脂质纳米粒子的审查的不同之处凸显了对该主题进一步监管的必要性。
更新日期:2023-04-28
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