Search Results - "García‐Arieta, Alfredo"

Interactions between active pharmaceutical ingredients and excipients affecting bioavailability: Impact on bioequivalence by García-Arieta, Alfredo

“…The aim of the present paper is to illustrate the impact that excipients may have on the bioavailability of drugs and to review existing US-FDA, WHO and EMA…”
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Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia by Pejčić, Zorica, Vučićević, Katarina, García‐Arieta, Alfredo, Miljković, Branislava

“…Aims Generic products can be regarded as therapeutically equivalent and switchable with the reference product. However, switchability between generics is…”
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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 Reig-López, Javier, Merino-Sanjuan, Matilde, García-Arieta, Alfredo, Mangas-Sanjuán, Victor

“…Atorvastatin is the most prescribed 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor used to lower cardiovascular risk and constitutes one of the…”
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Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective by 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

“…In the Guideline on the Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms, 6 the in vitro–in vivo correlation (IVIVC) framework is…”
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Investigation on the Existence of Sex‐By‐Formulation Interaction in Bioequivalence Trials by González‐Rojano, Esperanza, Marcotegui, Julio, Ochoa, Dolores, Román, Manuel, Álvarez, Covadonga, Gordon, John, Abad‐Santos, Francisco, García‐Arieta, Alfredo

“…The US Food and Drug Administration recommends that if a drug product is intended for use in both sexes, similar proportions should be recruited for…”
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On the Biopharmaceutics Classification System Biowaiver of Ibuprofen by García-Arieta, Alfredo, Gordon, John, Potthast, Henrike

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Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen by González‐Rojano, Esperanza, Marcotegui, Julio, Laredo, Leonor, Gwaza, Luther, Gordon, John, Portolés, Antonio, Vargas, Emilio, Morales‐Alcelay, Susana, García‐Arieta, Alfredo

“…According to the Ibuprofen Product‐Specific Bioequivalence Guidance of the European Medicines Agency, achiral bioanalytical methods are considered acceptable…”
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Response to ‘Sex‐by‐formulation interaction in bioequivalence studies: the importance of formulations and experimental conditions’ by Ibarra et al by González‐Rojano, Esperanza, Abad‐Santos, Francisco, Gordon, John, García‐Arieta, Alfredo

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In Vitro Dissolution as a Tool for Formulation Selection: Telmisartan Two-Step IVIVC by Ruiz Picazo, Alejandro, Martinez-Martinez, M, Colón-Useche, Sarin, Iriarte, Ramon, Sánchez-Dengra, Bárbara, González-Álvarez, Marta, García-Arieta, Alfredo, González-Álvarez, Isabel, Bermejo, Marival

“…The purpose of this investigation was to develop an exploratory two-step level A IVIVC for three telmisartan oral immediate release formulations, the reference…”
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Investigation on the possibility of biowaivers for ibuprofen by Alvarez, Covadonga, Núñez, Ignacio, Torrado, Juan J, Gordon, John, Potthast, Henrike, García-Arieta, Alfredo

“…The aim of the study was to investigate the ability of in vitro dissolution to ensure bioequivalence of ibuprofen products. Ibuprofen is a Biopharmaceutics…”
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Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union by García-Arieta, Alfredo, Gordon, John, Gwaza, Luther, Merino, Virginia, Mangas-Sanjuan, Víctor

“…The development of second-entry topical products is hampered by several factors. The excipient composition should be similar to the reference product because…”
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Evaluation of sex‐by‐formulation interaction in bioequivalence studies of efavirenz tablets by González‐Rojano, Esperanza, Abad‐Santos, Francisco, Ochoa, Dolores, Román, Manuel, Marcotegui, Julio, Álvarez, Covadonga, Gordon, John, García‐Arieta, Alfredo

“…Aims The existence of a sex‐by‐formulation interaction in bioequivalence studies implies that the bioequivalence results (i.e., the test/reference ratio of the…”
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Investigating the Discriminatory Power of BCS-Biowaiver in Vitro Methodology to Detect Bioavailability Differences between Immediate Release Products Containing a Class I Drug by Colón-Useche, Sarin, González-Álvarez, Isabel, Mangas-Sanjuan, Victor, González-Álvarez, Marta, Pastoriza, Pilar, Molina-Martínez, Irene, Bermejo, Marival, García-Arieta, Alfredo

“…The purpose of this work is to investigate the discriminatory power of the Biopharmaceutics Classification System (BCS)-biowaiver in vitro methodology, i.e.,…”
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High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy Subjects by Ochoa, Dolores, Saiz-Rodríguez, Miriam, González-Rojano, Esperanza, Román, Manuel, Sánchez-Rojas, Sergio, Wojnicz, Aneta, Ruiz-Nuño, Ana, García-Arieta, Alfredo, Abad-Santos, Francisco

“…Albendazole is a benzimidazole carbamate drug with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. It has been described that…”
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Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making by Reig-López, Javier, García-Arieta, Alfredo, Mangas-Sanjuán, Víctor, Merino-Sanjuán, Matilde

“…Atorvastatin (ATS) is the gold-standard treatment worldwide for the management of hypercholesterolemia and prevention of cardiovascular diseases associated…”
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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 Xu, Zhengguo, Mangas-Sanjuán, Víctor, Merino-Sanjuán, Matilde, Merino, Virginia, García-Arieta, Alfredo

“…Inter- and intra-batch variability of the quality attributes contribute to the uncertainty for demonstrating equivalent microstructure of post-approval changes…”
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Candesartan Cilexetil In Vitro-In Vivo Correlation: Predictive Dissolution as a Development Tool by Figueroa-Campos, Andrés, Sánchez-Dengra, Bárbara, Merino, Virginia, Dahan, Arik, González-Álvarez, Isabel, García-Arieta, Alfredo, González-Álvarez, Marta, Bermejo, Marival

“…The main objective of this investigation was to develop an in vitro in vivo correlation (IVIVC) for immediate release candesartan cilexetil formulations by…”
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Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients by González-Álvarez, Isabel, Sánchez-Dengra, Bárbara, Rodriguez-Galvez, Raquel, Ruiz-Picazo, Alejandro, González-Álvarez, Marta, García-Arieta, Alfredo, Bermejo, Marival

“…Some years ago, excipients were considered inert substances irrelevant in the absorption process. However, years of study have demonstrated that this belief is…”
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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 Mangas-Sanjuán, Víctor, Simón, Marta, González-Rojano, Esperanza, Ochoa, Dolores, Abad-Santos, Francisco, Román, Manuel, Ramos, Mercedes, Govantes, Carlos, García-Arieta, Alfredo

“…(1) Background: this article investigates which PK metrics in a single-dose study (concentration at the end of posology interval, C , partial areas under the…”
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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 Paixão, Paulo, Silva, Nuno, Guerreiro, Rita Bento, Blake, Kevin, Bonelli, Milton, Morais, José Augusto Guimarães, García-Arieta, Alfredo, Gouveia, Luís Filipe

“…Bioequivalence (BE) of products containing narrow therapeutic index (NTI) drugs in the European Union is currently established by demonstrating that the 90%…”
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