Ryosuke Kuribayashi

Tokyo, Japan

Last Updated: 09/26/2026

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Found 39 publications

Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan's 2025 Guidelines.

Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan's 2025 Guidelines.

Journal: Therapeutic innovation & regulatory science

Published: January 09, 2026

Adaptive inference through Bayesian and inverse Bayesian inference with symmetry bias in nonstationary environments.

Adaptive inference through Bayesian and inverse Bayesian inference with symmetry bias in nonstationary environments.

Journal: Bio Systems

Published: November 04, 2025

Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections.

Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections.

Journal: Frontiers in pharmacology

Published: September 26, 2025

Survey on the Role of Comparative Efficacy Studies Required for Biosimilar Monoclonal Antibody Approval in Japan to Justify the Quality Attribute Differences Between Biosimilars and Their Reference Products Based on the Pharmaceuticals and Medical Devices Agency (PMDA) Assessments.

Survey on the Role of Comparative Efficacy Studies Required for Biosimilar Monoclonal Antibody Approval in Japan to Justify the Quality Attribute Differences Between Biosimilars and Their Reference Products Based on the Pharmaceuticals and Medical Devices Agency (PMDA) Assessments.

Journal: Pharmaceutical medicine

Published: August 31, 2025

Consideration of the biosimilar drug lag and loss among Japan, the USA, and the EU.

Consideration of the biosimilar drug lag and loss among Japan, the USA, and the EU.

Journal: Naunyn-Schmiedeberg's archives of pharmacology

Published: May 24, 2025

Regulation for the Bioequivalence Evaluation of Generic Topical Dermatological Drug Products in Japan.

Regulation for the Bioequivalence Evaluation of Generic Topical Dermatological Drug Products in Japan.

Journal: European journal of drug metabolism and pharmacokinetics

Published: May 13, 2025

A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2.

A survey of regulatory recommendations for waivers of in vivo bioequivalence studies of generic products for certain dosage forms by participating regulators and organisations of the International Pharmaceutical Regulators Programme. Part 2.

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

Published: April 03, 2025

The 100th Monoclonal Antibody Product is Approved in Japan.

The 100th Monoclonal Antibody Product is Approved in Japan.

Journal: The AAPS journal

Published: March 06, 2025

The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference.

The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference.

Journal: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

Published: February 28, 2025

Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information.

Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information.

Journal: Naunyn-Schmiedeberg's archives of pharmacology

Published: November 15, 2024

Two decades of new drug approvals in Japan.

Two decades of new drug approvals in Japan.

Journal: Nature reviews. Drug discovery

Published: October 02, 2024

Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009-2023.

Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009-2023.

Journal: The AAPS journal

Published: July 17, 2024

Showing 1-12 of 39

Last Updated: 09/26/2026