Mutsuhiro Ikuma

Tokyo, Japan

Last Updated: 09/26/2026

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Found 14 publications

Concordance Between Pharmaceuticals and Medical Devices Agency Review and Ministry of Health, Labour and Welfare Decision Among New Drug Applications in Japan.

Concordance Between Pharmaceuticals and Medical Devices Agency Review and Ministry of Health, Labour and Welfare Decision Among New Drug Applications in Japan.

Journal: Clinical pharmacology and therapeutics

Published: June 01, 2024

Postmarket safety communications on drugs approved in Japan: A 25-year analysis.

Postmarket safety communications on drugs approved in Japan: A 25-year analysis.

Journal: Clinical and translational science

Published: January 17, 2024

Conditional early approval for new drug applications in Japan: Current and emerging issues.

Conditional early approval for new drug applications in Japan: Current and emerging issues.

Journal: Clinical and translational science

Published: January 09, 2023

Assessment of the impact of Japanese-specific long-term safety data on new drug approval.

Assessment of the impact of Japanese-specific long-term safety data on new drug approval.

Journal: Clinical and translational science

Published: April 15, 2021

The PMDA's view on the limited pipeline of nephrology drugs in Japan.

The PMDA's view on the limited pipeline of nephrology drugs in Japan.

Journal: Kidney international

Published: March 22, 2021

The PMDA Perspectives on New Oral Prolyl Hydroxylase Domain Enzyme Inhibitors for Renal Anemia.

The PMDA Perspectives on New Oral Prolyl Hydroxylase Domain Enzyme Inhibitors for Renal Anemia.

Journal: Clinical pharmacology and therapeutics

Published: December 03, 2020

Achievements and challenges of the Sakigake designation system in Japan.

Achievements and challenges of the Sakigake designation system in Japan.

Journal: British journal of clinical pharmacology

Published: October 24, 2020

Rationales of delay and difference in regulatory review by Japan, the USA and Europe among new drugs first approved in Japan.

Rationales of delay and difference in regulatory review by Japan, the USA and Europe among new drugs first approved in Japan.

Journal: British journal of clinical pharmacology

Published: October 13, 2020

Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.

Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.

Journal: Clinical pharmacology and therapeutics

Published: September 18, 2020

Role of Roxadustat for ESA-Resistant Renal Anemia? -Read with Caution.

Role of Roxadustat for ESA-Resistant Renal Anemia? -Read with Caution.

Journal: Journal of the American Society of Nephrology : JASN

Published: September 08, 2020

ESA Resistance May Be a Potential Confounder for Mortality among Different ESA Types.

ESA Resistance May Be a Potential Confounder for Mortality among Different ESA Types.

Journal: Journal of the American Society of Nephrology : JASN

Published: August 18, 2019

Exposure of drugs for hypertension, diabetes, and autoimmune disease during pregnancy and perinatal outcomes: an investigation of the regulator in Japan.

Exposure of drugs for hypertension, diabetes, and autoimmune disease during pregnancy and perinatal outcomes: an investigation of the regulator in Japan.

Journal: Medicine

Published: January 09, 2015

Showing 1-12 of 14

Last Updated: 09/26/2026