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Considerations for non-clinical safety studies of therapeutic peptide vaccines.
Matsumoto M, Komatsu S, Tsuchimoto M, Matsui H, Watanabe K, Nakamura K, Amakasu K, Ito K, Fueki O, Sawada J, Maki K, Onodera H. Matsumoto M, et al. Among authors: watanabe k. Regul Toxicol Pharmacol. 2014 Oct;70(1):254-60. doi: 10.1016/j.yrtph.2014.06.029. Epub 2014 Jul 17. Regul Toxicol Pharmacol. 2014. PMID: 25042360
Investigating toxicity specific to adjuvanted vaccines.
Matsumoto M, Komatsu SI, Ikeda T, Shimomura K, Watanabe K, Hirabayashi K, Sawada JI, Maki K, Shinoda K, Fueki O, Onodera H. Matsumoto M, et al. Among authors: watanabe k. Regul Toxicol Pharmacol. 2017 Dec;91:29-38. doi: 10.1016/j.yrtph.2017.09.003. Epub 2017 Sep 6. Regul Toxicol Pharmacol. 2017. PMID: 28888957 Review.
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.
Hirabayashi Y, Maki K, Kinoshita K, Nakazawa T, Obika S, Naota M, Watanabe K, Suzuki M, Arato T, Fujisaka A, Fueki O, Ito K, Onodera H. Hirabayashi Y, et al. Among authors: watanabe k. Nucleic Acid Ther. 2021 Apr;31(2):114-125. doi: 10.1089/nat.2020.0879. Epub 2021 Jan 19. Nucleic Acid Ther. 2021. PMID: 33470890 Free PMC article.
Qualitative analysis of actual Standard for Exchange of Nonclinical Data (SEND) datasets for Data Domains: Proposition from Japan Pharmaceutical Manufacturers Association SEND Taskforce Team on standardization of nonclinical data.
Sato G, Matsumoto I, Watanabe M, Kinomoto T, Nakajima M, Yamamoto M, Inoue Y, Kobayashi K, Tanaharu T, Kiya A, Yamaguchi T, Hayashi H, Motoyama K, Suzuki M, Watanabe K. Sato G, et al. Among authors: watanabe k, watanabe m. Regul Toxicol Pharmacol. 2021 Jun;122:104919. doi: 10.1016/j.yrtph.2021.104919. Epub 2021 Mar 20. Regul Toxicol Pharmacol. 2021. PMID: 33753112
Toxicologic Pathology Forum: Current Status on the Use of Animal Models of Human Disease in the Pharmaceutical Industry in Japan in Nonclinical Safety Assessment-Opinion Paper.
Tomohiro M, Okabe T, Kimura Y, Kinoshita K, Maeda M, Mitobe Y, Motoyama K, Yonezawa R, Sasaki S, Fujiwara M, Watanabe K. Tomohiro M, et al. Among authors: watanabe k. Toxicol Pathol. 2019 Feb;47(2):108-120. doi: 10.1177/0192623318816669. Epub 2019 Jan 13. Toxicol Pathol. 2019. PMID: 30636562
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