Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications by Ines Lenić, Kevin Blake, Alfredo Garcia‐Arieta, Henrike Potthast, Jan Welink

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Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making by Javier Reig-López, Alfredo García-Arieta, Víctor Mangas-Sanjuán, Matilde Merino-Sanjuán

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Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union by Alfredo García-Arieta, John Gordon, Luther Gwaza, Virginia Merino, Víctor Mangas-Sanjuan

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A physiologically based pharmacokinetic model for open acid and lactone forms of atorvastatin and metabolites to assess the drug-gene interaction with SLCO1B1 polymorphisms by Javier Reig-López, Matilde Merino-Sanjuan, Alfredo García-Arieta, Victor Mangas-Sanjuán

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Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms by Zhengguo Xu, Víctor Mangas-Sanjuán, Matilde Merino-Sanjuán, Virginia Merino, Alfredo García-Arieta

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Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients by Isabel González-Álvarez, Bárbara Sánchez-Dengra, Raquel Rodriguez-Galvez, Alejandro Ruiz-Picazo, Marta González-Álvarez, Alfredo García-Arieta, Marival Bermejo

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Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union by Paulo Paixão, Nuno Silva, Rita Bento Guerreiro, Kevin Blake, Milton Bonelli, José Augusto Guimarães Morais, Alfredo García-Arieta, Luís Filipe Gouveia

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Candesartan Cilexetil In Vitro–In Vivo Correlation: Predictive Dissolution as a Development Tool by Andrés Figueroa-Campos, Bárbara Sánchez-Dengra, Virginia Merino, Arik Dahan, Isabel González-Álvarez, Alfredo García-Arieta, Marta González-Álvarez, Marival Bermejo

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Alternative Pharmacokinetic Metrics in Single-Dose Studies to Ensure Bioequivalence of Prolonged-Release Products at Steady State—A Case Study by Víctor Mangas-Sanjuán, Marta Simón, Esperanza González-Rojano, Dolores Ochoa, Francisco Abad-Santos, Manuel Román, Mercedes Ramos, Carlos Govantes, Alfredo García-Arieta

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An In Vivo Predictive Dissolution Methodology (iPD Methodology) with a BCS Class IIb Drug Can Predict the In Vivo Bioequivalence Results: Etoricoxib Products by Isabel Gonzalez-Alvarez, Marival Bermejo, Yasuhiro Tsume, Alejandro Ruiz-Picazo, Marta Gonzalez-Alvarez, Bart Hens, Alfredo Garcia-Arieta, Greg E. Amidon, Gordon L. Amidon

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One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products by Mercedes Prieto-Escolar, Juan J. Torrado, Covadonga Álvarez, Alejandro Ruiz-Picazo, Marta Simón-Vázquez, Carlos Govantes, Jesús Frias, Alfredo García-Arieta, Isabel Gonzalez-Alvarez, Marival Bermejo

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Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective by Efthymios Manolis, Alfredo García‐Arieta, Anders Lindahl, Evangelos Kotzagiorgis, Jobst Limberg, Øyvind Holte, Paulo Paixao, Carolien Versantvoort, Flora Musuamba Tshinanu, Kevin Blake, Michiel Van Den Heuvel

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Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence by Víctor Mangas-Sanjuán, María Pleguezuelos-Villa, Matilde Merino-Sanjuán, Mª Jesús Hernández, Amparo Nácher, Alfredo García-Arieta, Daniel Peris, Irene Hidalgo, Lluís Soler, Marta Sallan, Virginia Merino

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Erratum: Mangas-Sanjuán, V.; et al. Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence. <i>... by Víctor Mangas-Sanjuán, María Pleguezuelos-Villa, Matilde Merino-Sanjuán, Mᵃ Jesús Hernández, Amparo Nácher, Alfredo García-Arieta, Daniel Peris, Irene Hidalgo, Lluís Soler, Marta Sallan, Virginia Merino

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Exploring Bioequivalence of Dexketoprofen Trometamol Drug Products with the Gastrointestinal Simulator (GIS) and Precipitation Pathways Analyses by Marival Bermejo, Gislaine Kuminek, Jozef Al-Gousous, Alejandro Ruiz-Picazo, Yasuhiro Tsume, Alfredo Garcia-Arieta, Isabel González-Alvarez, Bart Hens, Gregory E. Amidon, Nair Rodriguez-Hornedo, Gordon L. Amidon, Deanna Mudie

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High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy Subjects by Dolores Ochoa, Dolores Ochoa, Miriam Saiz-Rodríguez, Miriam Saiz-Rodríguez, Esperanza González-Rojano, Manuel Román, Manuel Román, Sergio Sánchez-Rojas, Aneta Wojnicz, Ana Ruiz-Nuño, Alfredo García-Arieta, Francisco Abad-Santos, Francisco Abad-Santos

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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... by Eduardo Agostinho Freitas Fernandes, Joy van Oudtshoorn, Andrew Tam, Liliana Carolina Arévalo González, Erwin Guzmán Aurela, Henrike Potthast, Katalina Mettke, Ryosuke Kuribayashi, Kohei Shimojo, Miho Kasuga, Lázaro Morales, Zulema Rodríguez, Ben Jones, Choongyul Ahn, Eunju Yun, So Hee Kim, Clare Rodrigues, Toh Tiong, Christopher Crane, Chantal Walther, Matthias S. Roost, Tzu-Ling Chen, Li-feng Hsu, April C. Braddy, Alfredo García-Arieta, Alfredo García-Arieta, Ivana Abalos, Milly Divinsky, Abdulaziz Alsuwyeh, Bader Alzenaidy, Adel Alharf

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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

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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

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

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