Kazushige Maki

Tokyo, Japan

Last Updated: 09/26/2026

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Found 14 publications

Minimizing use of nonhuman primates to inform risk to fertility and of adverse pregnancy outcomes with pharmaceuticals.

Minimizing use of nonhuman primates to inform risk to fertility and of adverse pregnancy outcomes with pharmaceuticals.

Journal: Regulatory toxicology and pharmacology : RTP

Published: August 04, 2025

Variation and classification of chemically-induced zebrafish malformations for the ICH S5 (R3) guideline: an atlas for zebrafish teratogenesis.

Variation and classification of chemically-induced zebrafish malformations for the ICH S5 (R3) guideline: an atlas for zebrafish teratogenesis.

Journal: The Journal of toxicological sciences

Published: August 03, 2025

Developmental and Reproductive Toxicity Testing Strategies for Oligonucleotides: A Workshop Proceedings.

Developmental and Reproductive Toxicity Testing Strategies for Oligonucleotides: A Workshop Proceedings.

Journal: Nucleic acid therapeutics

Published: May 30, 2025

Validation of a new protocol for a zebrafish MEFL (malformation or embryo-fetal lethality) test method that conforms to the ICH S5 (R3) guideline.

Validation of a new protocol for a zebrafish MEFL (malformation or embryo-fetal lethality) test method that conforms to the ICH S5 (R3) guideline.

Journal: The Journal of toxicological sciences

Published: August 04, 2024

Quality and Safety Considerations for Therapeutic Products Based on Extracellular Vesicles.

Quality and Safety Considerations for Therapeutic Products Based on Extracellular Vesicles.

Journal: Pharmaceutical research

Published: April 30, 2024

Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics.

Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics.

Journal: International journal of toxicology

Published: September 15, 2023

Addressing practical issues in the smooth implementation of revised guidelines for non-clinical studies of vaccines for infectious disease prevention.

Addressing practical issues in the smooth implementation of revised guidelines for non-clinical studies of vaccines for infectious disease prevention.

Journal: Regulatory toxicology and pharmacology : RTP

Published: December 14, 2022

Proposal for the revision of the guidelines for Non-clinical studies of vaccines for the prevention of infectious diseases in Japan.

Proposal for the revision of the guidelines for Non-clinical studies of vaccines for the prevention of infectious diseases in Japan.

Journal: Vaccine

Published: November 07, 2021

Nonclinical safety assessment of engineered T cell therapies.

Nonclinical safety assessment of engineered T cell therapies.

Journal: Regulatory toxicology and pharmacology : RTP

Published: May 14, 2021

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.

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.

Journal: Nucleic acid therapeutics

Published: January 20, 2021

Aspects of Gene Therapy Products Using Current Genome-Editing Technology in Japan.

Aspects of Gene Therapy Products Using Current Genome-Editing Technology in Japan.

Journal: Human gene therapy

Published: August 01, 2020

Investigating toxicity specific to adjuvanted vaccines.

Investigating toxicity specific to adjuvanted vaccines.

Journal: Regulatory toxicology and pharmacology : RTP

Published: March 07, 2017

Showing 1-12 of 14

Last Updated: 09/26/2026