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
Y. Hirabayashi, K. Maki, Kiyoshi Kinoshita, T. Nakazawa, S. Obika, M. Naota, Kazuto Watanabe, Mutsumi Suzuki, T. Arato, Aki Fujisaka, Osamu Fueki, K. Ito, H. Onodera
Nucleic Acid Therapeutics