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
Published 2019-09-01

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
Published 2021-05-01

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
Published 2020-11-01

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
Published 2020-07-01

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
Published 2021-04-01

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
Published 2021-05-01

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
Published 2020-05-01

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
Published 2019-10-01

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
Published 2019-03-01

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
Published 2021-04-01

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

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

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
Published 2020-08-01

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