Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications

por Lenić, Ines, Blake, Kevin, Garcia‐Arieta, Alfredo, Potthast, Henrike, Welink, Jan
Publicado 2019

Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making

por Reig-López, Javier, García-Arieta, Alfredo, Mangas-Sanjuán, Víctor, Merino-Sanjuán, Matilde
Publicado 2021

Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union

por García-Arieta, Alfredo, Gordon, John, Gwaza, Luther, Merino, Virginia, Mangas-Sanjuan, Víctor
Publicado 2023

Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms

por Xu, Zhengguo, Mangas-Sanjuán, Víctor, Merino-Sanjuán, Matilde, Merino, Virginia, García-Arieta, Alfredo
Publicado 2020

Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients

por González-Álvarez, Isabel, Sánchez-Dengra, Bárbara, Rodriguez-Galvez, Raquel, Ruiz-Picazo, Alejandro, González-Álvarez, Marta, García-Arieta, Alfredo, Bermejo, Marival
Publicado 2022

A multivariate investigation into the relationship between pharmaceutical characteristics and patient preferences of bioequivalent ibuprofen tablets

por Alonso, Tatiana R, Gagol, Adrianna, Scherer, Maximilian, Matji, Antonio, Torrado-Santiago, Santiago, Serrano, Dolores R, Garcia-Arieta, Alfredo, Torrado, Juan J
Publicado 2018

Candesartan Cilexetil In Vitro–In Vivo Correlation: Predictive Dissolution as a Development Tool

por Figueroa-Campos, Andrés, Sánchez-Dengra, Bárbara, Merino, Virginia, Dahan, Arik, González-Álvarez, Isabel, García-Arieta, Alfredo, González-Álvarez, Marta, Bermejo, Marival
Publicado 2020

Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union

por Paixão, Paulo, Silva, Nuno, Guerreiro, Rita Bento, Blake, Kevin, Bonelli, Milton, Morais, José Augusto Guimarães, García-Arieta, Alfredo, Gouveia, Luís Filipe
Publicado 2022

Alternative Pharmacokinetic Metrics in Single-Dose Studies to Ensure Bioequivalence of Prolonged-Release Products at Steady State—A Case Study

por Mangas-Sanjuán, Víctor, Simón, Marta, González-Rojano, Esperanza, Ochoa, Dolores, Abad-Santos, Francisco, Román, Manuel, Ramos, Mercedes, Govantes, Carlos, García-Arieta, Alfredo
Publicado 2023

Investigation to Explain Bioequivalence Failure in Pravastatin Immediate-Release Products

por Ruiz-Picazo, Alejandro, Colón-Useche, Sarin, Perez-Amorós, Blanca, González-Álvarez, Marta, Molina-Martínez, Irene, González-Álvarez, Isabel, García-Arieta, Alfredo, Bermejo, Marival
Publicado 2019

An In Vivo Predictive Dissolution Methodology (iPD Methodology) with a BCS Class IIb Drug Can Predict the In Vivo Bioequivalence Results: Etoricoxib Products

por Gonzalez-Alvarez, Isabel, Bermejo, Marival, Tsume, Yasuhiro, Ruiz-Picazo, Alejandro, Gonzalez-Alvarez, Marta, Hens, Bart, Garcia-Arieta, Alfredo, Amidon, Greg E., Amidon, Gordon L.
Publicado 2021

High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy Subjects

por Ochoa, Dolores, Saiz-Rodríguez, Miriam, González-Rojano, Esperanza, Román, Manuel, Sánchez-Rojas, Sergio, Wojnicz, Aneta, Ruiz-Nuño, Ana, García-Arieta, Alfredo, Abad-Santos, Francisco
Publicado 2021

Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective

por Manolis, Efthymios, García‐Arieta, Alfredo, Lindahl, Anders, Kotzagiorgis, Evangelos, Limberg, Jobst, Holte, Øyvind, Paixao, Paulo, Versantvoort, Carolien, Tshinanu, Flora Musuamba, Blake, Kevin, Van Den Heuvel, Michiel
Publicado 2023

One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products

por Prieto-Escolar, Mercedes, Torrado, Juan J., Álvarez, Covadonga, Ruiz-Picazo, Alejandro, Simón-Vázquez, Marta, Govantes, Carlos, Frias, Jesús, García-Arieta, Alfredo, Gonzalez-Alvarez, Isabel, Bermejo, Marival
Publicado 2021

Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence

por Mangas-Sanjuán, Víctor, Pleguezuelos-Villa, María, Merino-Sanjuán, Matilde, Hernández, Mª Jesús, Nácher, Amparo, García-Arieta, Alfredo, Peris, Daniel, Hidalgo, Irene, Soler, Lluís, Sallan, Marta, Merino, Virginia
Publicado 2019

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. Pha...

por Mangas-Sanjuán, Víctor, Pleguezuelos-Villa, María, Merino-Sanjuán, Matilde, Hernández, Mᵃ Jesús, Nácher, Amparo, García-Arieta, Alfredo, Peris, Daniel, Hidalgo, Irene, Soler, Lluís, Sallan, Marta, Merino, Virginia
Publicado 2020

Exploring Bioequivalence of Dexketoprofen Trometamol Drug Products with the Gastrointestinal Simulator (GIS) and Precipitation Pathways Analyses

por Bermejo, Marival, Kuminek, Gislaine, Al-Gousous, Jozef, Ruiz-Picazo, Alejandro, Tsume, Yasuhiro, Garcia-Arieta, Alfredo, González-Alvarez, Isabel, Hens, Bart, Mudie, Deanna, Amidon, Gregory E., Rodriguez-Hornedo, Nair, Amidon, Gordon L.
Publicado 2019