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Ryosuke Kuribayashi

Observed name: R. Kuribayashi
ORCID: 0000-0002-6778-7114
Observed ORCID: 0000-0002-6778-7114
OpenAlex ID: A5030909721
Mass spectrometric glycoform profiling of the innovator and biosimilar erythropoietin and darbepoetin by LC/ESI-MS
2013 · Akira Harazono, Noritaka Hashii, et al. · Journal of Pharmaceutical and Biomedical Analysis · 52
Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections
2025 · Ai Fukaya-Shiba, Akiko Ogata, et al. · Frontiers in Pharmacology · 41
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Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects
2015 · Ryosuke Kuribayashi, Maki Matsuhama, et al. · The AAPS Journal · 38
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A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme
2018 · Joy Elizabeth Van Oudtshoorn, Alfredo García-Arieta, et al. · Journal of Pharmacy & Pharmaceutical Sciences · 25
Rapid evaluation for heterogeneities in monoclonal antibodies by liquid chromatography/mass spectrometry with a column-switching system
2012 · Ryosuke Kuribayashi, Noritaka Hashii, et al. · Journal of Pharmaceutical and Biomedical Analysis · 22
Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan
2016 · Ryosuke Kuribayashi, Tomoko Takishita, et al. · Journal of Pharmaceutical Sciences · 20
Characterization of N‐glycan heterogeneities of erythropoietin products by liquid chromatography/mass spectrometry and multivariate analysis
2014 · Noritaka Hashii, Akira Harazono, et al. · Rapid Communications in Mass Spectrometry · 20
Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union
2016 · Ryosuke Kuribayashi, Toru Yamaguchi, et al. · Clinical Pharmacokinetics · 19
Current Japanese Regulatory Systems for Generics and Biosimilars
2017 · Ryosuke Kuribayashi, Kenji Sawanobori · Journal of Pharmaceutical Sciences · 13
The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities
2024 · Eduardo Agostinho Freitas Fernandes, Joy van Oudtshoorn, et al. · Journal of Pharmacy & Pharmaceutical Sciences · 12
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Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022
2023 · Ryosuke Kuribayashi, Ayuki Nakano, et al. · BioDrugs · 12
Modernization and Strengthening of Bioequivalence Guidelines in Japan
2020 · Ryosuke Kuribayashi, Toru Yamaguchi, et al. · Clinical Pharmacokinetics · 12
A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme
2019 · Alfredo Garcia Arieta, Craig Simon, et al. · Journal of Pharmacy & Pharmaceutical Sciences · 12
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The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
2019 · Christopher Crane, Gustavo Mendes Lima Santos, et al. · Journal of Pharmacy & Pharmaceutical Sciences · 11
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Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada
2017 · Ryosuke Kuribayashi, Scott Appleton · Drugs in R&D · 9
The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference
2025 · B. Schug, G. Beuerle, et al. · European Journal of Pharmaceutical Sciences · 8
Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan
2024 · Ryosuke Kuribayashi, Kanoko Goto, et al. · Expert Opinion on Biological Therapy · 7
Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments
2024 · Ryosuke Kuribayashi, Aya Hariu, et al. · Pharmaceutical Medicine · 7
A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme
2021 · Alfredo Garcia Arieta, Craig Simon, et al. · Journal of Pharmacy & Pharmaceutical Sciences · 7
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Current Regulation for Bioequivalence Evaluations of Generic Ophthalmic Dosage Forms in Japan
2020 · Aya Myoenzono, Ryosuke Kuribayashi, et al. · European Journal of Drug Metabolism and Pharmacokinetics · 6
Overexpression of heat shock protein 70 restores the structural stability and functional defects of temperature-sensitive mutant of large T antigen at nonpermissive temperature
2006 · Yoshiaki Tabuchi, Ryosuke Kuribayashi, et al. · Cell Stress and Chaperones · 6
Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
2021 · Matthias Shona Roost, Henrike Potthast, et al. · Journal of Pharmacy & Pharmaceutical Sciences · 5
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Current Understanding of the Equivalence Evaluations for In Vitro Tests on Generic Dry Powder Inhaler Drug Products in Japan
2019 · Ryosuke Kuribayashi, Aya Myoenzono, et al. · European Journal of Drug Metabolism and Pharmacokinetics · 5
New Gastric Epithelial Cell Lines from Mice Transgenic for Temperature-Sensitive Simian Virus 40 Large T Antigen Show Distinct Types of Cell Differentiation
2003 · Yoshiaki Tabuchi, Yuko Arai, et al. · Digestion · 5
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
2025 · Kanoko Goto, Aya Hariu, et al. · Pharmaceutical Medicine · 4
Works count: 43
Citation count: 403
H-index: 12
I10-index: 14
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