Rika Wakao

Tokyo, Japan

Last Updated: 09/26/2026

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Found 15 publications

Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA.

Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA.

Journal: Clinical and translational science

Published: February 13, 2026

In vivo CAR T cells and targeted gene delivery: A theme for the Pharmaceuticals and Medical Devices Agency Science Board to address.

In vivo CAR T cells and targeted gene delivery: A theme for the Pharmaceuticals and Medical Devices Agency Science Board to address.

Journal: Frontiers in medicine

Published: January 10, 2023

Analysis and enhancement of risk management for ethnic differences in antineoplastic drugs in Japan.

Analysis and enhancement of risk management for ethnic differences in antineoplastic drugs in Japan.

Journal: BMC health services research

Published: April 25, 2022

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity.

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity.

Journal: Frontiers in medicine

Published: August 11, 2021

Pharmaceuticals and Medical Devices Agency's horizon scanning and the Science Board: Cooperation toward extracellular vesicle-based products.

Pharmaceuticals and Medical Devices Agency's horizon scanning and the Science Board: Cooperation toward extracellular vesicle-based products.

Journal: British journal of clinical pharmacology

Published: June 08, 2021

The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan.

The Use of Subgroup Disproportionality Analyses to Explore the Sensitivity of a Global Database of Individual Case Safety Reports to Known Pharmacogenomic Risk Variants Common in Japan.

Journal: Drug safety

Published: March 07, 2021

Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting.

Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting.

Journal: Drug safety

Published: July 04, 2020

PMDA's Vision for Horizon Scanning of Emerging Technologies Potentially Relevant to the Development of New Medical Products: The Regulatory Challenge.

PMDA's Vision for Horizon Scanning of Emerging Technologies Potentially Relevant to the Development of New Medical Products: The Regulatory Challenge.

Journal: Clinical pharmacology and therapeutics

Published: March 04, 2020

Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.

Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA's perspective.

Journal: Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs

Published: January 05, 2020

Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports.

Data-Driven Identification of Adverse Event Reporting Patterns for Japan in VigiBase, the WHO Global Database of Individual Case Safety Reports.

Journal: Drug safety

Published: September 28, 2019

Mucosal-Associated Invariant T Cells in Regenerative Medicine.

Mucosal-Associated Invariant T Cells in Regenerative Medicine.

Journal: Frontiers in immunology

Published: July 14, 2017

Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence.

Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence.

Journal: Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques

Published: August 13, 2016

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Last Updated: 09/26/2026