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Regulatory guidelines and preclinical tools to study the biodistribution of RNA therapeutics
Adv Drug Deliv Rev. 2022 Mar 26;184:114236. doi: 10.1016/j.addr.2022.114236. Online ahead of print.ABSTRACTThe success of the messenger RNA-based COVID-19 vaccines of Moderna and Pfizer/BioNTech marks the beginning of a new chapter in modern medicine. However, the rapid rise of mRNA therapeutics has resulted in a regulatory framework that is somewhat lagging. The current guidelines either do not apply, do not mention RNA therapeutics, or do not have widely accepted definitions. This review describes the guidelines for preclinical biodistribution studies of mRNA/siRNA therapeutics and highlights the relevant differences for...
Source: Advanced Drug Delivery Reviews - March 30, 2022 Category: Drugs & Pharmacology Authors: P Vervaeke S E Borgos N N Sanders F Combes Source Type: research