Considerations of the Japanese Research Working Group for the ICH S6 & Related Issues Regarding Nonclinical Safety Assessments of Oligonucleotide Therapeutics: Comparison with Those of Biopharmaceuticals

This white paper summarizes the current consensus of the Japanese Research Working Group for the ICH S6 & Related Issues (WGS6) on strategies for the nonclinical safety assessment of oligonucleotide-based therapeutics (ONTs), specifically focused on the similarities and differences to biotechnol...

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Udgivet i:Nucleic Acid Ther
Main Authors: Hirabayashi, Yoko, Maki, Kazushige, Kinoshita, Kiyoshi, Nakazawa, Takahiro, Obika, Satoshi, Naota, Misaki, Watanabe, Kazuto, Suzuki, Mutsumi, Arato, Teruyo, Fujisaka, Aki, Fueki, Osamu, Ito, Kosuke, Onodera, Hiroshi
Format: Artigo
Sprog:Inglês
Udgivet: Mary Ann Liebert, Inc., publishers 2021
Fag:
Issues in Development
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC7997717/
https://ncbi.nlm.nih.gov/pubmed/33470890
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1089/nat.2020.0879
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