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Miho Kasuga

ORCID: 0000-0002-3158-5633
Observed ORCID: 0000-0002-3158-5633
OpenAlex ID: A5083976304
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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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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Regulation for the Bioequivalence Evaluation of Generic Topical Dermatological Drug Products in Japan
2025 · Miho Kasuga, Kimika Kuwana, et al. · European Journal of Drug Metabolism and Pharmacokinetics · 3
Generic Drug Product Development in Japan: Regulatory Updates During 2014–2019 and the Future
2021 · Miho Kasuga, Ryosuke Kuribayashi, et al. · European Journal of Drug Metabolism and Pharmacokinetics · 3
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
2025 · Alfredo García-Arieta, Andrew Tam, et al. · Journal of Pharmacy & Pharmaceutical Sciences · 1
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First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA
2022 · Ryosuke Kuribayashi, Miho Kasuga, et al. · Therapeutic Innovation & Regulatory Science · 1
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Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan’s 2025 Guidelines
2026 · Hiroyuki Yoshida, Yasuhiro Abe, et al. · Therapeutic Innovation & Regulatory Science
Current Situation and Challenges of Bioequivalence Evaluations for Drug Products for Topical Cutaneous Administration: From a Generic Drug Review Officer’s Perspective
2020 · Miho Kasuga, Kuribayashi Ryosuke
Works count: 9
Citation count: 25
H-index: 3
I10-index: 1
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