Kazushige Maki

Pharmaceuticals and Medical Devices Agency — Japan

Immunology and Microbiology · Life Sciences

19h-index3.4kcitations50works11.72yr avg
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Research Topics

T-cell and B-cell Immunology(12), Immune Cell Function and Interaction(11), Geological and Geochemical Analysis(6), Cytokine Signaling Pathways and Interactions(6), Immunotherapy and Immune Responses(5)

Publications50 total

Minimizing use of nonhuman primates to inform risk to fertility and of adverse pregnancy outcomes with pharmaceuticals
Regulatory Toxicology and Pharmacology·2025
Developmental and Reproductive Toxicity Testing Strategies for Oligonucleotides: A Workshop Proceedings
Nucleic Acid Therapeutics·2025· 2 cited
Variation and classification of chemically-induced zebrafish malformations for the ICH S5 (R3) guideline: an atlas for zebrafish teratogenesis
The Journal of Toxicological Sciences·2025· 2 citedOpen Access
Quality and Safety Considerations for Therapeutic Products Based on Extracellular Vesicles
Pharmaceutical Research·2024· 60 citedOpen Access
Points-to-consider: the mRNA vaccine reflection paper
Translational and Regulatory Sciences·2024· 1 citedOpen Access
Validation of a new protocol for a zebrafish MEFL (malformation or embryo-fetal lethality) test method that conforms to the ICH S5 (R3) guideline
The Journal of Toxicological Sciences·2024· 5 citedOpen Access
Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics
International Journal of Toxicology·2023· 7 cited
Addressing practical issues in the smooth implementation of revised guidelines for non-clinical studies of vaccines for infectious disease prevention
Regulatory Toxicology and Pharmacology·2023· 1 citedOpen Access
Points to consider for non-clinical safety evaluation of <i>in vivo</i> gene therapy products
Translational and Regulatory Sciences·2023Open Access
Proposal for the revision of the guidelines for Non-clinical studies of vaccines for the prevention of infectious diseases in Japan
Vaccine·2022· 3 cited
Nonclinical safety assessment of engineered T cell therapies
Regulatory Toxicology and Pharmacology·2021· 18 citedOpen Access
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
Nucleic Acid Therapeutics·2021· 16 citedOpen Access
Aspects of Gene Therapy Products Using Current Genome-Editing Technology in Japan
Human Gene Therapy·2020· 14 citedOpen Access
Application of Induced Pluripotent Stem Cells in Drug Discovery and Regenerative Medicine
2020
Preclinical safety assessments of mRNA-targeting oligonucleotide therapeutics
Translational and Regulatory Sciences·2020· 4 citedOpen Access
Investigating toxicity specific to adjuvanted vaccines
Regulatory Toxicology and Pharmacology·2017· 6 cited
Considerations for non-clinical safety studies of therapeutic peptide vaccines
Regulatory Toxicology and Pharmacology·2014· 6 cited
Petrogenesis of metatexite and diatexite migmatites determined using zircon U–Pb age, trace element and Hf isotope data, Higo metamorphic terrane, central Kyushu, Japan
Journal of Metamorphic Geology·2014· 31 cited
Regulatory Toxicology and Pharmacology
2014· 4 cited
Pressure–temperature structure of a mylonitized metamorphic pile, and the role of advection of the lower crust, Nagasaki Metamorphic Complex, Kyushu, Japan
Lithos·2013· 14 cited
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Frequent Co-authors

Koichi Ikuta(18), Jun‐ichi Miyazaki(7), Shinji Sunaga(6), Hiroshi Onodera(6), Hajime Karasuyama(5), Fumito Mikashima(5), Tzen‐Fu Yui(4), Kazuhiro Miyazaki(4), Mayuko Fukuyama(4), Kazuto Watanabe(4), Osamu Fueki(4), Mineo Matsumoto(4), Yoshinori Komagata(3), Hai‐Chon Lee(3), Teruhide Yamaguchi(3), Shizue Tani‐ichi(3), Uwe Martens(3), Marty Grove(3), Kisaburo Nagata(3), Misaki Naota(3)