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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... by Alfredo Garcia Arieta, Craig Simon, Gustavo Mendes Lima Santos, Iván Omar Calderón Lojero, Zulema Rodríguez Martínez, Clare Rodrigues, Sang Aeh Park, Ji Myoung Kim, Ryosuke Kuribayashi, Yusuke Okada, Arno Nolting, Chantal Pfäffli, Wen-Yi Hung, Christopher Crane, April C Braddy, Joy van Oudtshoorn, Diego Gutierrez Triana, Mitch Clarke
Published 2019-01-01
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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... by Joy Elizabeth van Oudtshoorn, Alfredo García-Arieta, Gustavo Mendes Lima Santos, Christopher Crane, Clare Rodrigues, Craig Simon, Ji Myoung Kim, Sang Aeh Park, Yusuke Okada, Ryosuke Kuribayashi, Chantal Pfäffli, Arno Nolting, Iván Omar Calderón Lojero, Zulema Rodríguez Martínez, Wen-Yi Hung, April C. Braddy, Nancy Arciniegas Leal, Diego Gutierrez Triana, Mitch Clarke, Peter Bachmann
Published 2018-03-01
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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... by Alfredo Garcia Arieta, Craig Simon, Andrew Tam, Gustavo Mendes Lima Santos, Eduardo Agostinho Freitas Fernandes, Zulema Rodríguez Martínez, Clare Rodrigues, Sang Aeh Park, JaYoung Kim, Kwansoo Kim, Ryosuke Kuribayashi, Aya Myoenzono, Kohei Shimojo, Chantal Walther, Matthias S. Roost, Wen-Yi Hung, Li-feng Hsu, Christopher Crane, April C. Braddy, Joy van Oudtshoorn, Diego Alejandro Gutierrez Triana, Erwin Guzmán Aurela, Ben Jones, Henrike Potthast, Ivana Abalos
Published 2021-03-01
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A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Prog... by Andrew Tam, Alfredo Garcia-Arieta, Ivana Abalos, Eduardo Agostinho Freitas Fernandes, Gustavo Mendes Lima Santos, Zulema Rodriguez Martinez, Milly Divinsky, Rami Kariv, Henrike Potthast, April C. Braddy, Clare Rodrigues, Erwin Guzman Aurela, Liliana Carolina Arevalo Gonzalez, Diego Gutierres Triana, Ben Jones, Choongyul Ahn, Hyuna Kim, So Hee Kim, Ryosuke Kuribayashi, Aya Myoenzono, Kohei Shimojo, Joy van Oudtshoorn, Cornelia Bigler, Ricarda Meincke, Matthias S. Roost, Chantal Walther, Li-feng Hsu, Christopher Crane, Tony Jarman
Published 2022-10-01
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Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organ... by Matthias Shona Roost, Henrike Potthast, Chantal Walther, Alfredo García-Arieta, Ivana Abalos, Eduardo Agostinho Freitas Fernandes, Gustavo Mendes Lima Santos, Zulema Rodríguez Martínez, Andrew Tam, Clare Rodrigues, Diego Alejandro Gutierrez Triana, Erwin Guzmán Aurela, Nayive Rodríguez Rodríguez, Sang Aeh Park, Jayoung Kim, Rami Kariv, Milly Divinsky, Ben Jones, Ryosuke Kuribayashi, Aya Myoenzono, Miho Kasuga, Joy van Oudtshoorn, Jo-Feng Chi, Wen-Yi Hung, Li-Feng Hsu, Christopher Crane, Tony Jarman, April Braddy
Published 2021-10-01
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