Modernization and Strengthening of Bioequivalence Guidelines in Japan von Kuribayashi, Ryosuke, Yamaguchi, Toru, Takagi, Kazunori

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First approval of generic dry powder inhaler drug products in Japan von Kuribayashi, Ryosuke, Myoenzono, Aya

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Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union von Kuribayashi, Ryosuke, Yamaguchi, Toru, Sako, Hanaka, Takishita, Tomoko, Takagi, Kazunori

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First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA von Kuribayashi, Ryosuke, Kasuga, Miho, Kuwana, Kimika, Yamaguchi, Toru

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Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects von Kuribayashi, Ryosuke, Matsuhama, Maki, Mikami, Kenichi

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Mass spectrometric glycoform profiling of the innovator and biosimilar erythropoietin and darbepoetin by LC/ESI-MS von Harazono, Akira, Hashii, Noritaka, Kuribayashi, Ryosuke, Nakazawa, Shiori, Kawasaki, Nana

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Current Understanding of the Equivalence Evaluations for In Vitro Tests on Generic Dry Powder Inhaler Drug Products in Japan von Kuribayashi, Ryosuke, Myoenzono, Aya, Takagi, Kazunori, Hirota, Mitsue

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Characterization of N-glycan heterogeneities of erythropoietin products by liquid chromatography/mass spectrometry and multivariate analysis von Hashii, Noritaka, Harazono, Akira, Kuribayashi, Ryosuke, Takakura, Daisuke, Kawasaki, Nana

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The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and... von Fernandes, Eduardo Agostinho Freitas, van Oudtshoorn, Joy, Tam, Andrew, González, Liliana Carolina Arévalo, Aurela, Erwin Guzmán, Potthast, Henrike, Mettke, Katalina, Kuribayashi, Ryosuke, Shimojo, Kohei, Kasuga, Miho, Morales, Lázaro, Rodríguez, Zulema, Jones, Ben, Ahn, Choongyul, Yun, Eunju, Kim, So Hee, Rodrigues, Clare, Tiong, Toh, Crane, Christopher, Walther, Chantal, Roost, Matthias S, Chen, Tzu-Ling, Hsu, Li-Feng, Braddy, April C, García-Arieta, Alfredo, Abalos, Ivana, Divinsky, Milly, Alsuwyeh, Abdulaziz, Alzenaidy, Bader, Alharf, Adel

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Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients von Matsuhama, Maki, Kuribayashi, Ryosuke

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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 o... von Garcia Arieta, Alfredo, Simon, Craig, Tam, Andrew, Mendes Lima Santos, Gustavo, Freitas Fernandes, Eduardo Agostinho, Rodríguez Martínez, Zulema, Rodrigues, Clare, Park, Sang Aeh, Kim, JaYoung, Kim, Kwansoo, Kuribayashi, Ryosuke, Myoenzono, Aya, Shimojo, Kohei, Walther, Chantal, Roost, Matthias S, Hung, Wen-Yi, Hsu, Li-Feng, Crane, Christopher, Braddy, April C, Van Oudtshoorn, Joy, Gutierrez Triana, Diego Alejandro, Guzmán Aurela, Erwin, Jones, Ben, Potthast, Henrike, Abalos, Ivana

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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... von Matsuhama, Maki, Takishita, Tomoko, Kuribayashi, Ryosuke, Takagi, Kazunori, Wakao, Rika, Mikami, Kenichi

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A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators... von Garcia Arieta, Alfredo, Simon, Craig, Lima Santos, Gustavo Mendes, Calderón Lojero, Iván Omar, Rodríguez Martínez, Zulema, Rodrigues, Clare, Park, Sang Aeh, Kim, Ji Myoung, Kuribayashi, Ryosuke, Okada, Yusuke, Nolting, Arno, Pfäffli, Chantal, Hung, Wen-Yi, Crane, Christopher, Braddy, April C, Van Oudtshoorn, Joy, Gutierrez Triana, Diego, Clarke, Mitch

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Current Japanese Regulatory Systems for Generics and Biosimilars von Kuribayashi, Ryosuke, Sawanobori, Kenji

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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 Regulat... von Van Oudtshoorn, Joy Elizabeth, García-Arieta, Alfredo, Santos, Gustavo Mendes Lima, Crane, Christopher, Rodrigues, Clare, Simon, Craig, Kim, Ji Myoung, Park, Sang Aeh, Okada, Yusuke, Kuribayashi, Ryosuke, Pfäffli, Chantal, Nolting, Arno, Lojero, Iván Omar Calderón, Martínez, Zulema Rodríguez, Hung, Wen-Yi, Braddy, April C, Leal, Nancy Arciniegas, Triana, Diego Gutierrez, Clarke, Mitch, Bachmann, Peter

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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... von Crane, Christopher, Santos, Gustavo Mendes Lima, Fernandes, Eduardo Agostinho Freitas, Simon, Craig, Tam, Andrew, Triana, Diego Gutierrez, Potthast, Henrike, Kuribayashi, Ryosuke, Okada, Yusuke, Myoenzono, Aya, Calderon, Ivan Omar, Rodriguez, Zulema, Jones, Ben, Park, Sang Aeh, Eum, So Young, Rodrigues, Clare, Van Oudsthoorn, Joy, Nolting, Arno, Walther, Chantal, Roost, Matthias S, Hung, Wen-Yi, Braddy, April C, Garcia-Arieta, Alfredo

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Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009–2023 von Kuribayashi, Ryosuke, Goto, Kanoko, Ogawa, Takumi

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Two decades of new drug approvals in Japan von Kuribayashi, Ryosuke, Hariu, Aya, Kishioka, Yasuhiro, Sakurai, Akira

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Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022 von Kuribayashi, Ryosuke, Nakano, Ayuki, Hariu, Aya, Kishioka, Yasuhiro, Honda, Futaba

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Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan von Kuribayashi, Ryosuke, Takishita, Tomoko, Mikami, Kenichi

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