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- W4220789950 endingPage "114236" @default.
- W4220789950 startingPage "114236" @default.
- W4220789950 abstract "The 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 mRNA vaccines. We also discuss the role of in vivo RNA imaging techniques and other assays to fulfill and/or complement the regulatory requirements. Specifically, quantitative whole-body autoradiography, microautoradiography, mass spectrometry-based assays, hybridization techniques (FISH, bDNA), PCR-based methods, in vivo fluorescence imaging, and in vivo bioluminescence imaging, are discussed. We conclude that this new and rapidly evolving class of medicines demands a multi-layered approach to fully understand its biodistribution and in vivo characteristics." @default.
- W4220789950 created "2022-04-03" @default.
- W4220789950 creator A5013719758 @default.
- W4220789950 creator A5024365503 @default.
- W4220789950 creator A5048595477 @default.
- W4220789950 creator A5087823072 @default.
- W4220789950 date "2022-05-01" @default.
- W4220789950 modified "2023-10-16" @default.
- W4220789950 title "Regulatory guidelines and preclinical tools to study the biodistribution of RNA therapeutics" @default.
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