Artículos científicos por temática

Última actualización: 21 de abril de 2026

Bioequivalence between generic tacrolimus products marketed in Spain by adjusted indirect comparison Herranz M, Morales-Alcelay S, Corredera-Hernández MT, de la Torre-Alvarado JM, Blázquez-Pérez A, Suárez-Gea ML, Alvarez C, García-Arieta A. Eur J Clin Pharmacol. 2013 May;69(5):1157-62. doi: 10.1007/s00228-012-1456-6. PMID:23196824.

Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen Cámara-Martinez I, Blechar JA, Ruiz-Picazo A, Garcia-Arieta A, Calandria C, Merino-Sanjuan V, Langguth P, Gonzalez-Alvarez M, Bermejo M, Al-Gousous J, Gonzalez-Alvarez I. Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen. Int J Pharm. 2022 Feb 25;614:121415. doi: 10.1016/j.ijpharm.2021.121415.
Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen
González-Rojano E, Marcotegui J, Laredo L, Gwaza L, Gordon J, Portolés A, Vargas E, Morales-Alcelay S, García-Arieta A. Chirality. 2020 Sep;32(9):1169-1177. doi: 10.1002/chir.23258. Epub 2020 Jun 29. PMID: 32602190
A multivariate investigation into the relationship between pharmaceutical characteristics and patient preferences of bioequivalent ibuprofen tablets Alonso TR, Gagol A, Scherer M, Matji A, Torrado-Santiago S, Serrano DR, Garcia-Arieta A, Torrado JJ. Patient Prefer Adherence. 2018 Sep 26;12:1927-1935. doi: 10.2147/PPA.S174479. eCollection 2018. PubMed PMID: 30288033; PubMed Central PMCID: PMC6163020.

EU-JAMRAI: Europe Fostering Synergies To Reduce The Burden of AMRIPC and Surveillance: AMR Control 2018 online Edition
Interchangeability between first-line generic antiretroviral products prequalified by WHO using adjusted indirect comparisons Gwaza L, Gordon J, Welink J, Potthast H, Leufkens H, Stahl M, García-Arieta A. Antivir Ther. 2016 Sep 20. doi: 10.3851/IMP3089. [Epub ahead of print] PubMed PMID: 27646863.
About the equivalence between different batches of a glycopeptide drug Boix-Montañes A, Garcia-Arieta A. Pharm Dev Technol. 2016 Aug;21(5):642-5. doi:10.3109/10837450.2015.1035726. PubMed PMID: 25886080.
Adjusted indirect treatment comparison of the bioavailability of WHO-prequalified first-line generic antituberculosis medicines Gwaza L, Gordon J, Welink J, Potthast H, Leufkens H, Stahl M, García-Arieta A. Clin Pharmacol Ther. 2014 Nov;96(5):580-8.
[Procedure for the marketing authorization of an antibacterial agent] López Navas A, García-Escribano Ráez N, Flores Juberías Á, Suárez Gea ML.Enferm Infecc Microbiol Clin. 2014 Oct; 32(8):529-32.
Global, regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013 GBD 2013 Mortality and Causes of Death Collaborators. Lancet. 2014;384(9947):1005-70.
Composition specification of teicoplanin based on its estimated relative bioavailability Boix-Montañes A, Garcia-Arieta A. Drug Dev Ind Pharm. 2015 Feb;41(2):218-23. doi: 10.3109/03639045.2013.858733. PMID: 24506456.
Uso de antibióticos en España y marco regulador para su desarrollo clínico en la Unión Europea Lázaro-Bengoa E, de Abajo Iglesias F, López-Navas A, Fernández-Cortizo MJ.Enferm Infecc Microbiol Clin. 2010;28(Supl 4):10-16.
Contribución al libro “La gripe aviar, ¿una nueva amenaza pandémica?” A. Portela y otros autores. Editado por el CSIC, 2007. Coordinado por J. Ortín.
Analysis of Spectinomycin by liquid chromatography with pulsed electrochemical detection Debremaecker D, Adams E, Nadal E, Van Hove B, Roets E, Hoogmartens J. Journal of Chromatography A, 2002, 953 (123-132).
Interlaboratory study of the analysis of benzylpenicillin by liquid chromatography Yongxin Z, Roets E, Loidl J, Inama P, Perez A, Porqueras E, Wachberger E, Lebbe C, Smelt AJ, Van der Vlies C, Miller JH, Spieser JM, Hoogmartens J, J Chromatogr B Biomed Sci Appl. 1998, 10; 707(1-2):189-93.
Interlaboratory study of the analysis of ampicillin by liquid chromatography Zhu Y, Moreno ML, Porqueras E, Bourke E, Bruzzi A, Aletrari M, Kanari P, Partasidou D, Nienhuis J, Ferigo W, Robert JL, Miller JH, Spieser JM, Roets E, Hoogmartens J. Journal of Pharmaceutical and Biomedical Analysis 1996, 14: 1151-1156.
Evaluation of liquid chromatography methods for the separation of ampicillin and its related substances Zhu Y, Roets E, Ni Z, Moreno ML, Porqueras E, Hoogmartens J. Journal of Pharmaceutical and Biomedical Analysis 1996, 14: 631-639.

Global Harmonization of Comparator Products for Bioequivalence Studies Gwaza L, Gordon J, Leufkens H, Stahl M, García-Arieta A. AAPS J. 2017 Mar 6. doi: 10.1208/s12248-017-0068-6. [Epub ahead of print] PMID: 28265983.
[Is it necessary to modify the normative of medical research when drugs are not the study objective? Response from the Spanish Agency of Medicines and Health Devices] de la Fuente Honrubia C, Macías Sain-Gerons D, Montero Corominas D. Med Clin (Barc). 2012;138(12):546-7.
Rutas administrativas y requisitos éticos y legales en la investigación biomédica con seres humanos en España: una guía para investigadores Administrative pathways and ethical and legal requirements to carry out biomedical research with human beings in Spain: a guideline for researchers Cabrero Feliu L, de Abajo Iglesias FJ, de la Fuente Honrubia C, Serrano Castro MA. Med Clin (Barc). 2012;139(3):118–125.
Funciones y actividad de la Oficina de Apoyo a la Investigación Clínica Independiente de la Agencia Española de Medicamentos y Productos Sanitarios Blázquez-Pérez A, García-López L, Piqueras-Picón A. Investigación Clínica y Bioética nº 75. 2012.
Regulación de los medicamentos genéricos: evidencias y mitos García Arieta A, Hernández García C, Avendaño Solá C. Inf Ter Sist Nac Salud. 2010: 34; 71-82.
Uso de antibióticos en España y marco regulador para su desarrollo clínico en la Unión Europea Lázaro-Bengoa E, de Abajo Iglesias F, López-Navas A, Fernández-Cortizo MJ.Enferm Infecc Microbiol Clin. 2010;28(Supl 4):10-16.
Clinical trials on drugs authorised in Spain during 2007 and 2008 Serrano Castro MA, Labrador Cañadas MV, González Colaço C, Vargas Castrillón E. Med Clin (Barc). 2010 Mar 13;134(7):316-22.
Uso compasivo de medicamentos: un cambio necesario en España Avendaño C. Med Clin (Barc). 2009;133(11):425–426.
Nuevo real decreto de acceso a medicamentos en situaciones especiales Montero D, Vargas E, de la Cruz C, de Andrés Trelles F. Med Clin (Barc). 2009;133(11):427–432.
Review of legislation regarding clinical research in the Spanish health care system and hospital pharmacy services Laguna-Goya N, Serrano MA, Gómez-Chacón C. Farm Hosp. 2009 Sep-Oct;33(5):281-4.
Bases regulatorias de los medicamentos de origen biotecnológico Timón M, Ruiz S. Revista Española de Economía de la Salud. 2007; 6 (6): 346-351.
Regulation about generics approval Laguna-Goya N, Blázquez-Pérez A, Pozo-Hernández C. Farm Hosp. 2006 Nov-Dec;30(6):379-84. Review. Spanish.
Drug evaluation and approval process in the European Union San Miguel MT, Vargas E. Arthritis Rheum. 2006 Feb 15;55(1):12-4. No abstract available.
Quality of observational post-authorization studies registered in Spain before their regulation Zafrilla BP, García del Pozo J, Ros AA, de Abajo FJ. Med Clin (Barc). 2006 Apr 29;126(16):607-10.
Limitación de la dosis de radiaciones para los sujetos participantes en programas de investigación médica o biomédica con radiofármacos: normativa aplicable en España Cortés-Blanco A, Fernández Pérez I, Esteban Gómez J. Seguridad Nuclear 2004;31:7-14.
Radiofármacos de uso humano: marco legal e indicaciones clínicas autorizadas en España Cortés-Blanco A, Esteban Gómez J. Seguridad Nuclear 2003;26 (I Trimestre):5-16.
Autorización de comercialización de vacunas F Salmerón García, Aurora Limia Sánchez. Vacunaciones preceptivas. Principios y aplicaciones. Luis Salleras. 25 ed. Masson SA 2003, nº 37 741-752.
Helsinki Declaration VI: a necessary revision, but sufficient? de Abajo FJ. Rev Esp Salud Publica. 2001 Sep-Oct;75(5):407-19.
Medications as a solution and a problem for public health. Brief overview of the pharmacoepidemiologic objectives de Abajo FJ. Rev Esp Salud Publica. 2001 Jul-Aug;75(4):281-3.
Ticlopidine use in Spain: a pharmacy-based drug utilization study del Pino AM, de Abajo FJ, Montero D, Madurga M, Martín-Serrano G. Med Clin (Barc). 2000 Jul 8;115(6):211-3.

Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients González-Álvarez I, Sánchez-Dengra B, Rodriguez-Galvez R, Ruiz-Picazo A, González-Álvarez M, García-Arieta A, Bermejo M. Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients. Pharmaceutics. 2022 Nov 23;14(12):2565. doi: 10.3390/pharmaceutics14122565.
One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products Prieto-Escolar M, Torrado JJ, Álvarez C, Ruiz-Picazo A, Simón-Vázquez M, Govantes C, Frias J, García-Arieta A, Gonzalez-Alvarez I, Bermejo M. One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products. Pharmaceutics. 2021 May 11;13(5):690. doi: 10.3390/pharmaceutics13050690.
Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union Paixão P, Silva N, Guerreiro RB, Blake K, Bonelli M, Morais JAG, García-Arieta A, Gouveia LF. Evaluation of a Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union. Pharmaceutics. 2022 Oct 31;14(11):2349. doi: 10.3390/pharmaceutics14112349.
A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme Tam A, Garcia-Arieta A, Abalos I, Agostinho Freitas Fernandes E, Mendes Lima Santos G, Rodriguez Martinez Z, Divinsky M, Kariv R, Potthast H, Braddy AC, Rodrigues C, Guzman Aurela E, Carolina Arevalo Gonzalez L, Gutierres Triana D, Jones B, Ahn C, Kim H, Kim SH, Kuribayashi R, Myoenzono A, Shimojo K, Van Oudtshoorn J, Bigler C, Meincke R, Roost MS, Walther C, Hsu LF, Crane C, Jarman T. A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme. J Pharm Pharm Sci. 2022;25:323-339. doi: 10.18433/jpps33081.
Estimators and confidence intervals of f2 using bootstrap methodology for the comparison of dissolution profiles Xu Z, Merino-Sanjuan M, Mangas-Sanjuan V, García-Arieta A. Estimators and confidence intervals of f2 using bootstrap methodology for the comparison of dissolution profiles. Comput Methods Programs Biomed. 2021 Nov;212:106449. doi: 10.1016/j.cmpb.2021.106449.
Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations Roost MS, Potthast H, Walther C, García-Arieta A, Abalos I, Agostinho Freitas Fernandes E, Mendes Lima Santos G, Rodríguez Martínez Z, Tam A, Rodrigues C, Gutierrez Triana DA, Guzmán Aurela E, Rodríguez Rodríguez N, Aeh Park S, Kim J, Kariv R, Divinsky M, Jones B, Kuribayashi R, Myoenzono A, Kasuga M, Van Oudtshoorn J, Chi JF, Hung WY, Hsu LF, Crane C, Jarman T, Braddy A. Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities. J Pharm Pharm Sci. 2021;24:548-562. doi: 10.18433/jpps32260.
A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union Paixão P, Guerreiro RB, Silva N, Blake K, Bonelli M, Morais JAG, Garcia Arieta A, Gouveia LF. A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union. Clin Pharmacol Ther. 2022 Feb;111(2):470-476. doi: 10.1002/cpt.2451.
Trends in Cosmetics: Product Packaging at the Point of Sale Belén Borja Guerrero, Aránzazu López Pecharromán and Rosario C. Sánchez León. Cosmetics 2022, 9, 27. https:// doi.org/10.3390/cosmetics9020027
Estimators and confidence intervals of f2 using bootstrap methodology for the comparison of dissolution profiles Xu Z, Merino-Sanjuan M, Mangas-Sanjuan V, García-Arieta A. Estimators and confidence intervals of f2 using bootstrap methodology for the comparison of dissolution profiles. Comput Methods Programs Biomed. 2021 Nov;212:106449. doi: 10.1016/j.cmpb.2021.106449.
High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy Subjects
Ochoa D, Saiz-Rodríguez M, González-Rojano E, Román M, Sánchez-Rojas S, Wojnicz A, Ruiz-Nuño A, García-Arieta A, Abad-Santos F. Front Pharmacol. 2021 Apr 15;12:664465. doi: 10.3389/fphar.2021.664465. eCollection 2021. PMID: 33935787
An In Vivo Predictive Dissolution Methodology (iPD Methodology) with a BCS Class IIb Drug Can Predict the In Vivo Bioequivalence Results: Etoricoxib Products
Gonzalez-Alvarez I, Bermejo M, Tsume Y, Ruiz-Picazo A, Gonzalez-Alvarez M, Hens B, Garcia-Arieta A, Amidon GE, Amidon GL. Pharmaceutics. 2021 Apr 7;13(4):507. doi: 10.3390/pharmaceutics13040507. PMID: 33917118
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 of the International Pharmaceutical Regulators Programme
Garcia Arieta A, Simon C, Tam A, Mendes Lima Santos G, Freitas Fernandes EA, Rodríguez Martínez Z, Rodrigues C, Park SA, Kim J, Kim K, Kuribayashi R, Myoenzono A, Shimojo K, Walther C, Roost MS, Hung WY, Hsu LF, Crane C, Braddy AC, Van Oudtshoorn J, Gutierrez Triana DA, Guzmán Aurela E, Jones B, Potthast H, Abalos I. J Pharm Pharm Sci. 2021;24:113-126. doi: 10.18433/jpps31491. PMID: 33734975
Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms
Xu Z, Mangas-Sanjuán V, Merino-Sanjuán M, Merino V, García-Arieta A. Pharmaceutics. 2020 Nov 28;12(12):1159. doi: 10.3390/pharmaceutics12121159. PMID: 33260792; PMCID: PMC7760601
Candesartan Cilexetil In Vitro-In Vivo Correlation: Predictive Dissolution as a Development Tool
Figueroa-Campos A, Sánchez-Dengra B, Merino V, Dahan A, González-Álvarez I, García-Arieta A, González-Álvarez M, Bermejo M. Pharmaceutics. 2020 Jul 6;12(7):633. doi: 10.3390/pharmaceutics12070633. PMID: 32640620; PMCID: PMC7408357
Chiral bioanalytical methods in bioequivalence studies of intravenous vs. oral formulations of ibuprofen
González-Rojano E, Marcotegui J, Laredo L, Gwaza L, Gordon J, Portolés A, Vargas E, Morales-Alcelay S, García-Arieta A. Chirality. 2020 Sep;32(9):1169-1177. doi: 10.1002/chir.23258. Epub 2020 Jun 29. PMID: 32602190
Comparison of free software platforms for the calculation of the 90% confidence interval of f2 similarity factor by bootstrap analysis
Noce L, Gwaza L, Mangas-Sanjuan V, Garcia-Arieta A. Eur J Pharm Sci. 2020 Apr 15;146:105259. doi: 10.1016/j.ejps.2020.105259. Epub 2020 Feb 10. PMID: 32058055
Effect of enantiomerism on the bioequivalence of a new ibuprofen 600-mg tablet formulation obtained by roller compaction
Matji A, Vargas E, Carvajal L, Terleira AI, Portolés A, Garcia-Arieta A, Torrado JJ, Serrano DR. Chirality. 2020 Feb;32(2):185-190. doi: 10.1002/chir.23148. Epub 2019 Nov 22. PMID: 31755587
Investigation to Explain Bioequivalence Failure in Pravastatin Immediate-Release Products
Ruiz-Picazo A, Colón-Useche S, Perez-Amorós B, González-Álvarez M, Molina-Martínez I, González-Álvarez I, García-Arieta A, Bermejo M. Pharmaceutics. 2019 Dec 9;11(12):663. doi: 10.3390/pharmaceutics11120663. PMID: 31835294; PMCID: PMC6956045
Assessment of the Inter-Batch Variability of Microstructure Parameters in Topical Semisolids and Impact on the Demonstration of Equivalence
Mangas-Sanjuán V, Pleguezuelos-Villa M, Merino-Sanjuán M, Hernández MJ, Nácher A, García-Arieta A, Peris D, Hidalgo I, Soler L, Sallan M, Merino V. Pharmaceutics. 2019 Oct 1;11(10):503. doi: 10.3390/pharmaceutics11100503. Erratum in: Pharmaceutics. 2020 May 09;12(5): PMID: 31581492; PMCID: PMC6835722
The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
Crane C, Santos GML, Fernandes EAF, Simon C, Tam A, Triana DG, Potthast H, Kuribayashi R, Okada Y, Myoenzono A, Calderon IO, Rodriguez Z, Jones B, Park SA, Eum SY, Rodrigues C, Van Oudsthoorn J, Nolting A, Walther C, Roost MS, Hung WY, Braddy AC, Garcia-Arieta A. J Pharm Pharm Sci. 2019;22(1):486-500. doi: 10.18433/jpps30724. PMID: 33760728
Investigation on the existence of sex-by-formulation interaction in bioequivalence trials González-Rojano E, Marcotegui J, Ochoa D, Román M, Álvarez C, Gordon J, Abad-Santos F, García-Arieta A. Clin Pharmacol Ther. 2019 Jun 10. doi: 10.1002/cpt.1539. [Epub ahead of print] PubMed PMID: 31183851.
Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia Pejčić Z, Vučićević K, García-Arieta A, Miljković B. Br J Clin Pharmacol. 2019 May 29. doi: 10.1111/bcp.13997. [Epub ahead of print] PubMed PMID: 31140620.
Overview of the European Medicines Agency’s Experience With Biowaivers in Centralized Applications Lenić I, Blake K, Garcia-Arieta A, Potthast H, Welink J. Clin Transl Sci. 2019 May 2. doi: 10.1111/cts.12642. [Epub ahead of print] PubMed PMID: 31046182.
Exploring Bioequivalence of Dexketoprofen Trometamol Drug Products with the Gastrointestinal Simulator (GIS) and Precipitation Pathways Analyses Bermejo M, Kuminek G, Al-Gousous J, Ruiz-Picazo A, Tsume Y, Garcia-Arieta A, González-Alvarez I, Hens B, Amidon GE, Rodriguez-Hornedo N, Amidon GL, Mudie D. Pharmaceutics. 2019 Mar 15;11(3). pii: E122. doi: 10.3390/pharmaceutics11030122. PubMed PMID: 30884755; PubMed Central PMCID: PMC6471271.
Sex-by-formulation interaction in bioequivalence trials with transdermal patches González-Rojano E, Marcotegui J, Morales-Alcelay S, Álvarez C, Gordon J, Abad-Santos F, García-Arieta A. Eur J Clin Pharmacol. 2019 Jun;75(6):801-808. doi: 10.1007/s00228-019-02632-1. Epub 2019 Feb 6. PubMed PMID: 30725220.
A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme. Garcia Arieta A, Simon C, Lima Santos GM, Calderón Lojero IO, Rodríguez Martínez Z, Rodrigues C, Park SA, Kim JM, Kuribayashi R, Okada Y, Nolting A, Pfäffli C, Hung WY, Crane C, Braddy AC, Van Oudtshoorn J, Gutierrez Triana D, Clarke M. J Pharm Pharm Sci. 2019;22(1):28-36. doi: 10.18433/jpps30215. PubMed PMID: 30599818.
In Vitro Dissolution as a Tool for Formulation Selection: Telmisartan Two-Step IVIVC Ruiz Picazo A, Martinez-Martinez MT, Colón-Useche S, Iriarte R, Sánchez-Dengra B, González-Álvarez M, García-Arieta A, González-Álvarez I, Bermejo M. Mol Pharm. 2018 Jun 4;15(6):2307-2315. doi: 10.1021/acs.molpharmaceut.8b00153. Epub 2018 May 17. PubMed PMID: 29746133.
Defining level A IVIVC dissolution specifications based on individual in vitro dissolution profiles of a controlled release formulation González-García I, García-Arieta A, Merino-Sanjuan M, Mangas-Sanjuan V, Bermejo M. Eur J Pharm Sci. 2018 Jul 1;119:200-207. doi: 10.1016/j.ejps.2018.04.025. Epub 2018 Apr 20. PubMed PMID: 29680456.
Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets González-Rojano E, Abad-Santos F, Ochoa D, Román M, Marcotegui J, Álvarez C, Gordon J, García-Arieta A. Br J Clin Pharmacol. 2018 Aug;84(8):1729-1737. doi: 10.1111/bcp.13601. Epub 2018 May 22. PubMed PMID: 29633302; PubMed Central PMCID: PMC6046483.
Computer simulations for bioequivalence trials: Selection of analyte in BCS class II and IV drugs with first-pass metabolism, two metabolic pathways and intestinal efflux transporter Mangas-Sanjuan V, Navarro-Fontestad C, García-Arieta A, Trocóniz IF, Bermejo M. Eur J Pharm Sci. 2018 May 30;117:193-203. doi: 10.1016/j.ejps.2018.02.014. Epub 2018 Feb 13. PubMed PMID: 29452210.
IVIVC approach based on carbamazepine bioequivalence studies combination González-García I, Mangas-Sanjuan V, Merino-Sanjuán M, Álvarez-Álvarez C, Díaz-Garzón Marco J, Rodríguez-Bonnín MA, Langguth T, Torrado-Durán JJ, Langguth P, García-Arieta A, Bermejo M. Pharmazie. 2017 Aug 1;72(8):449-455. doi: 10.1691/ph.2017.7011. PubMed PMID: 29441903.
Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme Van Oudtshoorn JE, García-Arieta A, Santos GML, Crane C, Rodrigues C, Simon C, Kim JM, Park SA, Okada Y, Kuribayashi R, Pfäffli C, Nolting A, Lojero IOC, Martínez ZR, Hung WY, Braddy AC, Leal NA, Triana DG, Clarke M, Bachmann P. A. J Pharm Pharm Sci. 2018;21(1):27-37. doi: 10.18433/J3X93K. PubMed PMID: 29382433.
Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission Cardot JM, Garcia-Arieta A, Paixao P, Tasevska I, Davit B. Eur J Pharm Sci. 2018 Jan 1;111:399-408. doi: 10.1016/j.ejps.2017.10.013. Epub 2017 Oct 12. Review. PubMed PMID: 29032306.
Global Harmonization of Comparator Products for Bioequivalence Studies Gwaza L, Gordon J, Leufkens H, Stahl M, García-Arieta A. AAPS J. 2017 Mar 6. doi: 10.1208/s12248-017-0068-6. [Epub ahead of print] PMID: 28265983.
Assessment of the Regulatory Methods for the Comparison of Highly Variable Dissolution Profiles Mangas-Sanjuan V, Colon-Useche S, Gonzalez-Alvarez I, Bermejo M, Garcia-Arieta A. AAPS J. 2016 Nov;18(6):1550-1561. PubMed PMID: 27571779.
Interchangeability between first-line generic antiretroviral products prequalified by WHO using adjusted indirect comparisons Gwaza L, Gordon J, Welink J, Potthast H, Leufkens H, Stahl M, García-Arieta A. Antivir Ther. 2016 Sep 20. doi: 10.3851/IMP3089. [Epub ahead of print] PubMed PMID: 27646863.
About the equivalence between different batches of a glycopeptide drug Boix-Montañes A, Garcia-Arieta A. Pharm Dev Technol. 2016 Aug;21(5):642-5. doi:10.3109/10837450.2015.1035726. PubMed PMID: 25886080.
Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches Cardot JM, Garcia Arieta A, Paixao P, Tasevska I, Davit B. AAPS J. 2016 Jul;18(4):1039-46. doi: 10.1208/s12248-016-9915-0. Review. PubMed PMID: 27116020.
Impact of Chiral Bioanalytical Methods on the Bioequivalence of Ibuprofen Products Containing Ibuprofen Lysinate and Ibuprofen Base García-Arieta A, Ferrero-Cafiero JM, Puntes M, Gich I, Morales-Alcelay S, Tarré M, Font X, Antonijoan RM. Chirality. 2016 May;28(5):429-33. doi: 10.1002/chir.22598. PubMed PMID: 27094918.
On the Effect of Common Excipients on the Oral Absorption of Class 3 Drugs García-Arieta A, Gordon J, Potthast H. J Pharm Sci. 2016 Apr;105(4):1353-4. doi: 10.1016/j.xphs.2016.01.005. PubMed PMID: 27019955.
Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India Lee SL, Saluja B, García-Arieta A, Santos GM, Li Y, Lu S, Hou S, Rebello J, Vaidya A, Gogtay J, Purandare S, Lyapustina S. AAPS J. 2015 Sep;17(5):1285-304. doi: 10.1208/s12248-015-9787-8. PubMed PMID: 26002510; PubMed Central PMCID: PMC4540743.
Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons Gwaza L, Gordon J, Potthast H, Welink J, Leufkens H, Stahl M, García-Arieta A. Eur J Clin Pharmacol. 2015 Sep;71(9):1083-9. doi: 10.1007/s00228-015-1889-9. PubMed PMID: 26105964.
Agitation Rate and Time for Complete Dissolution in BCS Biowaivers Based on Investigation of a BCS Biowaiver for Dexketoprofen Tablets Garcia-Arieta A, Gordon J, Gwaza L, Mangas-Sanjuan V, Álvarez C, Torrado JJ. Mol Pharm. 2015 Sep 8;12(9):3194-201. doi: 10.1021/acs.molpharmaceut.5b00131. PubMed PMID: 26237401.
Investigating the Discriminatory Power of BCS-Biowaiver in Vitro Methodology to Detect Bioavailability Differences between Immediate Release Products Containing a Class I Drug Colón-Useche S, González-Álvarez I, Mangas-Sanjuan V, González-Álvarez M, Pastoriza P, Molina-Martínez I, Bermejo M, García-Arieta A. Mol Pharm. 2015 Sep 8;12(9):3167-74. doi:10.1021/acs.molpharmaceut.5b00076. PubMed PMID: 26287948.
On the Biopharmaceutics Classification System Biowaiver of Ibuprofen García-Arieta A, Gordon J, Potthast H. J Pharm Sci. 2015 Aug;104(8):2429-32. doi:10.1002/jps.24519. PubMed PMID: 26036644.
Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid Cuesta-Gragera A, Navarro-Fontestad C, Mangas-Sanjuan V, González-Álvarez I, García-Arieta A, Trocóniz IF, Casabó VG, Bermejo M. Eur J Pharm Sci. 2015 Jul 10; 74:86-94. doi: 10.1016/j.ejps.2015.04.002. PubMed PMID: 25869458.
On the Incorrect Statistical Calculations of the Kinetica Software Package in Imbalanced Designs Morales-Alcelay S, de la Torre de Alvarado JM, García-Arieta A. AAPS J. 2015 Jul; 17(4):1033-4. doi: 10.1208/s12248-015-9749-1. PubMed PMID: 25787313; PubMed Central PMCID: PMC4476979.
Validation of a semi-physiological model for caffeine in healthy subjects and cirrhotic patients Cuesta-Gragera A, Navarro-Fontestad C, Mangas-Sanjuan V, González-Álvarez I, García-Arieta A, Trocóniz IF, Casabó VG, Bermejo M. Eur J Pharm Sci. 2015 Jun 20;73:57-63. doi: 10.1016/j.ejps.2015.03.018. PubMed PMID: 25843043.
On the BCS biowaivers of orally disintegrating tablets García-Arieta A, Gordon J. Eur J Pharm Sci. 2015 Jan 23; 66:107-108.
A European Perspective on Orally Inhaled Products: In Vitro Requirements for a Biowaiver García-Arieta A. J Aerosol Med Pulm Drug Deliv. 2014, 27(6): 419-429.
Interactions between active pharmaceutical ingredients and excipients affecting bioavailability: Impact on bioequivalence García-Arieta A. Eur J Pharm Sci. 2014 Sep 16; 65: 89-97.
Mitos y realidades sobre los medicamentos biosimilares Hernández-García C. Reumatol Clin. 2014;10:351–352.
Adjusted indirect treatment comparison of the bioavailability of WHO-prequalified first-line generic antituberculosis medicines Gwaza L, Gordon J, Welink J, Potthast H, Leufkens H, Stahl M, García-Arieta A. Clin Pharmacol Ther. 2014 Nov;96(5):580-8.
Bioequivalence between generic tacrolimus products marketed in Spain by adjusted indirect comparison Herranz M, Morales-Alcelay S, Corredera-Hernández MT, de la Torre-Alvarado JM, Blázquez-Pérez A, Suárez-Gea ML, Alvarez C, García-Arieta A. Eur J Clin Pharmacol. 2013 May;69(5):1157-62. doi: 10.1007/s00228-012-1456-6. PMID:23196824.
Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO Gwaza L, Gordon J, Welink J, Potthast H, Hansson H, Stahl M, García-Arieta A. Eur J Clin Pharmacol. 2012 Dec;68(12):1611-8. doi: 10.1007/s00228-012-1396-1. PMID: 23011014.
Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalence Polli JE, Cook JA, Davit BM, Dickinson PA, Argenti D, Barbour N, García-Arieta A, Geoffroy JM, Hartauer K, Li S, Mitra A, Muller FX, Purohit V, Sanchez-Felix M, Skoug JW, Tang K. AAPS J. 2012 Sep;14(3):627-38. doi: 10.1208/s12248-012-9376-z. PMID: 22684402.
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Regulatory considerations for generic or biosimilar low molecular weight heparins Garcia-Arieta A, Blazquez A. Curr Drug Discov Technol. 2012 Jun 1;9(2):137-42.
Assessing bioequivalence of generic antiepilepsy drugs by indirect comparisons García Arieta A. Ann Neurol. 2012 May; 71(5):724-5; author reply 725. doi: 10.1002/ana.23583.
Reasons to Use Stereoselective Assay Methods Garcia Arieta A. Chirality. 2012 Apr 23. doi: 10.1002/chir.22022.
Investigation on the need of multiple dose bioequivalence studies for prolonged-release generic products García-Arieta A, Morales-Alcelay S, Herranz M, de la Torre-Alvarado JM, Blázquez-Pérez A, Suárez-Gea ML, Alvarez C.Int J Pharm. 2012 Feb 28;423(2):321-5.
Bioequivalence requirements in the European union: critical discussion García-Arieta A, Gordon J. AAPS J. 2012 Dec;14(4):738-48. doi: 10.1208/s12248-012-9382-1.
In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen Tsume Y, Langguth P, Garcia-Arieta A, Amidon GL. Biopharm Drug Dispos. 2012 Oct;33(7):366-77. doi: 10.1002/bdd.1800.
Establishing bioequivalence for orally inhaled drug products Arieta AG. Expert Opin Drug Deliv. 2011 Nov;8(11):1533-4.
Investigation on the possibility of biowaivers for ibuprofen Álvarez C, Núñez I, Torrado JJ, Gordon J, Potthast H, García-Arieta A. J Pharm Sci. 2011 Jun;100(6):2343-9.
Interchangeability among therapeutics equivalents of lamotrigine Garcia-Arieta A, Blazquez-Perez A.Rev Neurol. 2011 Mar 1;52(5):319-20; author reply 320.
Similar biological medicinal products: Lessons learned and challenges ahead Ruiz S, Calvo G. Journal of Generic Medicines. 2011; 8: 4-13.
Computer simulations for bioequivalence trials: selection of analyte in BCS drugs with first-pass metabolism and two metabolic pathways Navarro-Fontestad C, González-Álvarez I, Fernández-Teruel C, García-Arieta A, Bermejo M, Casabó VG. Eur J Pharm Sci. 2010 Dec 23;41(5):716-28.
Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies Torrado JJ, Blanco M, Farré M, Roset P, García-Arieta A. Eur J Clin Pharmacol. 2010 Jun;66(6):599-604. doi: 10.1007/s00228-010-0792-7. PMID: 20195587.
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An eutomer/distomer ratio near unity does not justify non-enantiospecific assay methods in bioequivalence studies García-Arieta A, Abad-Santos F, Rodríguez-Martínez MA, Varas-Polo Y, Novalbos J, Laparidis N, Gallego-Sandín S, Orfanidis K, Torrado J. Chirality. 2005 Oct;17(8):470-5.

Inhibition of 2A-mediated ‘cleavage’ of certain artificial polyproteins bearing N-terminal signal sequences P. de Felipe, G. A. Luke, J. D. Brown & M. D. Ryan. Biotechnology Journal. 2010; 5:213-223.
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The transcription factor Snail control epithelial-mesenchymal transitions by repressing E-cadherin expresion A. Cano, M.A. Pérez-Moreno, I. Rodrigo, A. Locascio, M.J. Blanco, M.G. del Barrio, F. Portillo y M.A. Nieto. Nature Cell Biol. 2000, 2:76-83.
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Homeopatía y productos homeopáticos. Evaluación de las evidencias acerca de su eficacia y seguridad
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Network meta-analysis for comparing treatment effects of multiple interventions: an introduction Catalá-López F, Tobías A, Cameron C, Moher D, Hutton B. Rheumatol Int. 2014;34(11):1489-96.
The transitive property across randomized controlled trials: if B is better than A, and C is better than B, will C be better than A? Catalá-López F, Hutton B, Moher D. Rev Esp Cardiol (Engl Ed). 2014;67(8):597-602.
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[Risks of dual blockade of the renin-angiotensin system compared with monotherapy: a systematic review and cumulative meta-analysis of randomized trials and observational studies] Catalá-López F, Macías Saint-Gerons D, de la Fuente Honrubia C, Martín-Serrano G. Rev Esp Salud Publica. 2014;88(1):37-65.
Global collaborative networks on meta-analyses of randomized trials published in high impact factor medical journals: a social network analysis Catalá-López F, Alonso-Arroyo A, Hutton B, Aleixandre-Benavent R, Moher D. BMC Med. 2014;12:15.
Inverse and direct cancer comorbidity in people with central nervous system disorders: a meta-analysis of cancer incidence in 577,013 participants of 50 observational studies Catalá-López F, Suárez-Pinilla M, Suárez-Pinilla P, Valderas JM, Gómez-Beneyto M, Martinez S, Balanzá-Martínez V, Climent J, Valencia A, McGrath J, Crespo-Facorro B, Sanchez-Moreno J, Vieta E, Tabarés-Seisdedos R. Psychother Psychosom. 2014;83:89-105.
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Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective Manolis E, García-Arieta A, Lindahl A, Kotzagiorgis E, Limberg J, Holte Ø, Paixao P, Versantvoort C, Tshinanu FM, Blake K, Van Den Heuvel M. Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective. CPT Pharmacometrics Syst Pharmacol. 2023 Jan 11. doi: 10.1002/psp4.12906.
A physiologically based pharmacokinetic model for open acid and lactone forms of atorvastatin and metabolites to assess the drug-gene interaction with SLCO1B1 polymorphisms Reig-López J, Merino-Sanjuan M, García-Arieta A, Mangas-Sanjuán V. A physiologically based pharmacokinetic model for open acid and lactone forms of atorvastatin and metabolites to assess the drug-gene interaction with SLCO1B1 polymorphisms. Biomed Pharmacother. 2022 Dec;156:113914. doi: 10.1016/j.biopha.2022.113914.
Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen Cámara-Martinez I, Blechar JA, Ruiz-Picazo A, Garcia-Arieta A, Calandria C, Merino-Sanjuan V, Langguth P, Gonzalez-Alvarez M, Bermejo M, Al-Gousous J, Gonzalez-Alvarez I. Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen. Int J Pharm. 2022 Feb 25;614:121415. doi: 10.1016/j.ijpharm.2021.121415.
Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making. Pharmaceutics Reig-López J, García-Arieta A, Mangas-Sanjuán V, Merino-Sanjuán M. Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making. Pharmaceutics. 2021 May 13;13(5):709. doi: 10.3390/pharmaceutics13050709.
One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products Prieto-Escolar M, Torrado JJ, Álvarez C, Ruiz-Picazo A, Simón-Vázquez M, Govantes C, Frias J, García-Arieta A, Gonzalez-Alvarez I, Bermejo M. One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products. Pharmaceutics. 2021 May 11;13(5):690. doi: 10.3390/pharmaceutics13050690.
About the equivalence between different batches of a glycopeptide drug Boix-Montañes A, Garcia-Arieta A. Pharm Dev Technol. 2016 Aug;21(5):642-5. doi:10.3109/10837450.2015.1035726. PubMed PMID: 25886080.
Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid Cuesta-Gragera A, Navarro-Fontestad C, Mangas-Sanjuan V, González-Álvarez I, García-Arieta A, Trocóniz IF, Casabó VG, Bermejo M. Eur J Pharm Sci. 2015 Jul 10; 74:86-94. doi: 10.1016/j.ejps.2015.04.002. PubMed PMID: 25869458.
Validation of a semi-physiological model for caffeine in healthy subjects and cirrhotic patients Cuesta-Gragera A, Navarro-Fontestad C, Mangas-Sanjuan V, González-Álvarez I, García-Arieta A, Trocóniz IF, Casabó VG, Bermejo M. Eur J Pharm Sci. 2015 Jun 20;73:57-63. doi: 10.1016/j.ejps.2015.03.018. PubMed PMID: 25843043.
Sensitive studies with a significant dose-response curve for inhaled corticosteroids to investigate equivalent relative potency are feasible García-Arieta A. Br J Clin Pharmacol. 2011 Nov;72(5):832-3.
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The INN global nomenclature of biological medicines: A continuous challenge. James S. Robertson, Wai-Keung Chui, Armando A. Genazzani, Sarel F. Malan, Ana López de la Rica Manjavacas, Gilles Mignot, Robin Thorpe, Raffaella Balocco, Menico Rizzi. Biologicals 60 (2019) 15–23.

Sensitive studies with a significant dose-response curve for inhaled corticosteroids to investigate equivalent relative potency are feasible García-Arieta A. Br J Clin Pharmacol. 2011 Nov;72(5):832-3.

High-Fat Breakfast Increases Bioavailability of Albendazole Compared to Low-Fat Breakfast: Single-Dose Study in Healthy Subjects
Ochoa D, Saiz-Rodríguez M, González-Rojano E, Román M, Sánchez-Rojas S, Wojnicz A, Ruiz-Nuño A, García-Arieta A, Abad-Santos F. Front Pharmacol. 2021 Apr 15;12:664465. doi: 10.3389/fphar.2021.664465. eCollection 2021. PMID: 33935787
Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO Gwaza L, Gordon J, Welink J, Potthast H, Hansson H, Stahl M, García-Arieta A. Eur J Clin Pharmacol. 2012 Dec;68(12):1611-8. doi: 10.1007/s00228-012-1396-1. PMID: 23011014.

Trends in Cosmetics: Product Packaging at the Point of Sale Belén Borja Guerrero, Aránzazu López Pecharromán and Rosario C. Sánchez León. Cosmetics 2022, 9, 27. https:// doi.org/10.3390/cosmetics9020027
Cosmetovigilancia en el registro español de investigación en dermatitis y alergia de contacto. Revisión de las declaraciones de reacciones adversas graves a la agencia española del medicamento y productos sanitarios Leopoldo Borrego¹; ME. Gatica Ortega²; P. Mercader García³; C. Arizmendi Vélez⁴; R. Sánchez León⁴; M. de Vega⁵; I. García Doval⁵
1. Complejo Hospitalario Universitario Insular Materno Infantil. Universidad de Las Palmas de Gran Canaria; 2. Complejo Hospitalario Universitario Toledo; 3. Hospital General Universitario Jose Mª Morales Meseguer, Murcia; 4. Productos Cosméticos. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS); 5. Unidad de Investigación. Fundación Piel Sana. AEDV (5), Madrid
Fuente: 66 Reunión del Grupo Español en Investigación de Dermatitis de Contacto y Alergia Cutánea.
COSMETOVIGILANCIA: ANÁLISIS DEL HEMA Y DI-HEMA C. Arizmendi Velez, R. Sanchez Leon, L.M. Lopez Sanchez.
Agencia Española de Medicamentos y Productos Sanitarios.
Fuente: Gaceta Sanitaria Especial Congreso – Volumen 34 – Octubre 2020.
I Congreso Virtual de la Sociedad Española de Epidemiología (SEE) y da Associação Portuguesa de Epidemiologia (APE). Página 202.
LEGISLACIÓN SANDACH: ¿EN QUÉ AFECTA A LOS PRODUCTOS COSMÉTICOS? Autoras: Arizmendi Vélez, Cristina, Técnico superior AEMPS; Sánchez León Rosario C., Consejera técnica de productos cosméticos AEMPS; Ferrer Montesa, Mª José, Evaluadora Medicamentos Inmunológicos Veterinarios AEMPS.
Fuente: NCP Noticias de Cosmética y Perfumería. Sociedad Española de Químicos Cosméticos. Noviembre/Diciembre 2020.
Reglamento de productos cosméticos. Notificación de efectos graves no deseados Sánchez León RC, Moreno Luquero M, Abad Luna MC. NCP. 2014 Mar-Abr; (336):5-8.
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Survey on the use and behaviour of metal-metal hip replacements in Spain Calcerrada N, Fernández-Vega A, Valls-León C, Garcia-Cimbrelo E. Rev Esp Cir Ortop Traumatol. 2016 Jan-Feb;60(1):20-8. PubMed PMID: 26381801.
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Florbetapir (¹⁸F) for brain amyloid PET: highlights on the European marketing approval Cortes-Blanco A, Prieto-Yerro C, Martinez-Lazaro R, Zamora J, Jiménez-Huete A, Haberkamp M, et al. Alzheimers & Dementia 2014;10:1-5.
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Información incluida en la ficha técnica de los radiofármacos de uso humano autorizados para comercialización en España Cortés-Blanco A, López de la Rica Manjavacas, Martínez-Lázaro R, Vargas Castrillón S, Cutanda Henríquez F, Hernández García C. Rev Esp Med Nucl 2011;30:41-6.
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Especificaciones actuales de la ficha técnica de los radiofármacos compuestos de fludesoxiglucosa (¹⁸F) autorizados para comercialización en España Cortés-Blanco A. Seguridad Nuclear 2006;40:21-8.
Condiciones autorizadas de uso humano en la práctica clínica de los generadores de molibdeno-99/tecnecio-99m (⁹⁹Mo/^99mTc) comercializados en España Cortés-Blanco A, Martínez Lázaro R. Seguridad Nuclear 2006;39:13-20.
Limitación de la dosis de radiaciones para los sujetos participantes en programas de investigación médica o biomédica con radiofármacos: normativa aplicable en España Cortés-Blanco A, Fernández Pérez I, Esteban Gómez J. Seguridad Nuclear 2004;31:7-14.
Radiofármacos de uso humano: marco legal e indicaciones clínicas autorizadas en España Cortés-Blanco A, Esteban Gómez J. Seguridad Nuclear 2003;26 (I Trimestre):5-16.
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Environmental risk assessment of veterinary medicinal products intended for use in aquaculture in Europe: the need for developing a harmonised approach
Irene de la Casa‑Resino, Michael T. Empl, Sara Villa, Boris Kolar, Julia Fabrega, Adam D. Lillicrap, Xanthippos N. Karamanlis and Ricardo Carapeto‑García
Veterinary medicinal products: how much environmental information would be available for developing a monograph?
De la Casa-Resino, I., Haro Castuera, A., Casimiro Elena, R., Rubio Montejano, C., Carapeto-García, R.
European legislation for veterinary medicines: Would a monograph system improve the environmental risk assessment?
Irene de la Casa‐Resino, Amparo Haro Castuera, Ramiro Casimiro Elena, Consuelo Rubio Montejano y Ricardo Carapeto García.

Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid Cuesta-Gragera A, Navarro-Fontestad C, Mangas-Sanjuan V, González-Álvarez I, García-Arieta A, Trocóniz IF, Casabó VG, Bermejo M. Eur J Pharm Sci. 2015 Jul 10; 74:86-94. doi: 10.1016/j.ejps.2015.04.002. PubMed PMID: 25869458.
Causes of Death in Anticoagulated Patients With Atrial Fibrillation Gómez-Outes A, Lagunar-Ruíz J, Terleira-Fernández AI, Calvo-Rojas G, Suárez-Gea ML, Vargas-Castrillón E. J Am Coll Cardiol. 2016;68(23):2508-2521.
Direct oral anticoagulants for stroke prevention in patients with atrial fibrillation: meta-analysis by geographic region with a focus on European patients Gómez-Outes A, Terleira-Fernández AI, Calvo-Rojas G, Suárez-Gea ML, Vargas-Castrillón E. Br J Clin Pharmacol. 2016;82(3):633-44.
Antidotes for the new oral anticoagulants: Reality and expectations Gómez-Outes A, Lecumberri R. Med Clin (Barc). 2016;146(11):488-90.
Direct-acting oral anticoagulants: pharmacology, indications, management, and future perspectives Gómez-Outes A, Suárez-Gea ML, Lecumberri R, Terleira-Fernández AI, Vargas-Castrillón E. Eur J Haematol. 2015;95(5):389-404.
Case Fatality Rates of Recurrent Thromboembolism and Bleeding in Patients Receiving Direct Oral Anticoagulants for the Initial and Extended Treatment of Venous Thromboembolism: A Systematic Review Gómez-Outes A, Lecumberri R, Suárez-Gea ML, Terleira-Fernández AI, Monreal M, Vargas-Castrillón E. J Cardiovasc Pharmacol Ther. 2015;20(5):490-500.
Specific Antidotes in Development for Reversal of Novel Anticoagulants: a Review. Gómez-Outes A, Suárez-Gea ML, Lecumberri R, Terleira-Fernandez AI, Vargas-Castrillon E. Recent Pat Cardiovasc Drug Discov. 2014 Dec 5. [Epub ahead of print].
Direct oral anticoagulants in the treatment of venous thromboembolism, with a focus on patients with pulmonary embolism: an evidence-based review Gómez-Outes A, Suárez-Gea ML, Lecumberri R, Terleira-Fernández AI, Vargas-Castrillón E. Vasc Health Risk Manag. 2014;10:627-39.
Direct oral anticoagulants in the treatment of acute venous thromboembolism: a systematic review and meta-analysis Gómez-Outes A, Terleira-Fernández AI, Lecumberri R, Suárez-Gea ML, Vargas-Castrillón E. Thromb Res. 2014;134(4):774-82.
Dabigatran, Rivaroxaban, or Apixaban versus Warfarin in Patients with Nonvalvular Atrial Fibrillation: A Systematic Review and Meta-Analysis of Subgroups Gómez-Outes A, Terleira-Fernández AI, Calvo-Rojas G, Suárez-Gea ML, Vargas-Castrillón E. Thrombosis. 2013;2013:640723.
Impact of assigning heart failure as the underlying cause of death on the calculation of premature mortality due to cardiovascular disease in Spain Gènova-Maleras R, Fernández de Larrea-Baz N, Álvarez-Martín E, Morant-Ginestar C, Catalá-López F. Rev Esp Cardiol (Engl Ed). 2013 Dec;66(12):1004-5.
Potential role of new anticoagulants for prevention and treatment of venous thromboembolism in cancer patients Gómez-Outes A, Suárez-Gea ML, Lecumberri R, Terleira-Fernández AI, Vargas-Castrillón E, Rocha E. Vasc Health Risk Manag. 2013;9:207-28.
Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons Gómez-Outes A, Terleira-Fernández AI, Suárez-Gea ML, Vargas-Castrillón E. BMJ. 2012; 344: e3675.
Discovery of anticoagulant drugs: a historical perspective Gomez-Outes A, Suarez-Gea ML, Calvo-Rojas G, Lecumberri R, Rocha E, Pozo-Hernandez C, Terleira-Fernandez AI, Vargas-Castrillon E. Curr Drug Discov Technol. 2012; 9(2): 83-104.
Clinical drug development in thromboembolic diseases: regulatory and methodological approach Calvo-Rojas G, Gomez-Outes A. Curr Drug Discov Technol. 2012; 9(2): 105-18.
Regulatory considerations for generic or biosimilar low molecular weight heparins Garcia-Arieta A, Blazquez A. Curr Drug Discov Technol. 2012 Jun 1;9(2):137-42.
Nuevos anticoagulantes parenterales en desarrollo clínico Gómez-Outes A, Suárez-Gea ML, Lecumberri R, Rocha E, Pozo-Hernández C, Vargas-Castrillón E. Actualidad en Farmacología y Terapéutica. 2011; 9(3): 167-81.
New parenteral anticoagulants in development Gómez-Outes A, Suárez-Gea ML, Lecumberri R, Rocha E, Pozo-Hernández C, Vargas-Castrillón E. Ther Adv Cardiovasc Dis. 2011; 5(1): 33-59.
Apixaban or enoxaparin for thromboprophylaxis Gómez-Outes A, Suárez-Gea ML, Pozo-Hernández C. N Engl J Med. 2009;361(21):2100-1.
Rivaroxaban versus enoxaparin after total knee arthroplasty Gómez-Outes A, Suárez-Gea ML, Blázquez-Pérez A, Pozo-Hernández C, Vargas-Castrillón E.Lancet. 2009 Aug 29;374(9691):682; author reply 683.
New anticoagulants: focus on venous thromboembolism Gómez-Outes A, Lecumberri R, Pozo C, Rocha E. Curr Vasc Pharmacol. 2009 Jul;7(3):309-29.
Ticlopidine use in Spain: a pharmacy-based drug utilization study del Pino AM, de Abajo FJ, Montero D, Madurga M, Martín-Serrano G. Med Clin (Barc). 2000 Jul 8;115(6):211-3.

A physiologically based pharmacokinetic model for open acid and lactone forms of atorvastatin and metabolites to assess the drug-gene interaction with SLCO1B1 polymorphisms Reig-López J, Merino-Sanjuan M, García-Arieta A, Mangas-Sanjuán V. A physiologically based pharmacokinetic model for open acid and lactone forms of atorvastatin and metabolites to assess the drug-gene interaction with SLCO1B1 polymorphisms. Biomed Pharmacother. 2022 Dec;156:113914. doi: 10.1016/j.biopha.2022.113914.
Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making. Pharmaceutics Reig-López J, García-Arieta A, Mangas-Sanjuán V, Merino-Sanjuán M. Current Evidence, Challenges, and Opportunities of Physiologically Based Pharmacokinetic Models of Atorvastatin for Decision Making. Pharmaceutics. 2021 May 13;13(5):709. doi: 10.3390/pharmaceutics13050709.
Statins Use and Risk of Cataracts: Firm Conclusions Are Still Far Off Saint-Gerons DM, Honrubia CD, Montero D, González-Bermejo D, Andrés-Trelles FD, Catalá-López F. J Cardiovasc Pharmacol Ther. 2014;pii: 1074248414557890.
[Primary prevention of cardiovascular diseases with statins in patients with diabetes] Macías Saint-Gerons D, de la Fuente Honrubia C, de Andrés-Trelles F, Catalá-López F. Med Clin (Barc). 2014;pii: S0025-7753(14)00341-8.
[Hepatotoxicity in patients treated with endothelin receptor antagonists: systematic review and meta-analysis of randomized clinical trials] Macías Saint-Gerons D, de la Fuente Honrubia C, Montero Corominas D, Catalá-López F. Med Clin (Barc). 2014;142(8):333-42.
Progressive chronic kidney disease and dual inhibition of the renin-angiotensin-aldosterone system Catalá-López F, Macías Saint-Gerons D, de la Fuente Honrubia C, Montero D.Prev Med. 2014;60:136.
Large streamlined trials in cardiovascular disease. Calvo G, McMurray JJ, Granger CB, Alonso-García Á, Armstrong P, Flather M, Gómez-Outes A, Pocock S, Stockbridge N, Svensson A, Van de Werf F. Eur Heart J. 2014;35(9):544-8.
[Risks of dual blockade of the renin-angiotensin system compared with monotherapy: a systematic review and cumulative meta-analysis of randomized trials and observational studies] Catalá-López F, Macías Saint-Gerons D, de la Fuente Honrubia C, Martín-Serrano G. Rev Esp Salud Publica. 2014;88(1):37-65.
Standard and intensive lipid-lowering therapy with statins for the primary prevention of vascular diseases: a population-based study Macías Saint-Gerons D, de la Fuente Honrubia C, Montero Corominas D, Gil MJ, de Andrés-Trelles F, Catalá-López F. Eur J Clin Pharmacol. 2014;70(1):99-108.
Diabetes mellitus and risks of dual blockade of the renin-angiotensin-aldosterone system Catalá-López F, Macías Saint-Gerons D. Rev Esp Cardiol (Engl Ed). 2013;66(5):412-5.
Endothelin receptor antagonists-induced hepatotoxicity Macías Saint-Gerons D, de la Fuente Honrubia C, Montero D, Catalá-López F. Intern Med J. 2013;43(5):609-10.
Olmesartan for the prevention or delay of diabetic nephropathy: some considerations Catalá-López F, Martín-Serrano G, Maciá MA, Montero D. Rev Esp Cardiol (Engl Ed). 2012;65(7):678-9.

Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients González-Álvarez I, Sánchez-Dengra B, Rodriguez-Galvez R, Ruiz-Picazo A, González-Álvarez M, García-Arieta A, Bermejo M. Exploring a Bioequivalence Failure for Silodosin Products Due to Disintegrant Excipients. Pharmaceutics. 2022 Nov 23;14(12):2565. doi: 10.3390/pharmaceutics14122565.
Labor induction with dinoprostone or oxytocine and postpartum disseminated intravascular coagulation: a hospital-based case-control study de Abajo FJ, Meseguer CM, Antiñolo G, García Rodríguez LA, Montero D, Castillo JR, Torelló J. Am J Obstet Gynecol. 2004 Nov;191(5):1637-43.

Impact of Chiral Bioanalytical Methods on the Bioequivalence of Ibuprofen Products Containing Ibuprofen Lysinate and Ibuprofen Base García-Arieta A, Ferrero-Cafiero JM, Puntes M, Gich I, Morales-Alcelay S, Tarré M, Font X, Antonijoan RM. Chirality. 2016 May;28(5):429-33. doi: 10.1002/chir.22598. PubMed PMID: 27094918.
Agitation Rate and Time for Complete Dissolution in BCS Biowaivers Based on Investigation of a BCS Biowaiver for Dexketoprofen Tablets Garcia-Arieta A, Gordon J, Gwaza L, Mangas-Sanjuan V, Álvarez C, Torrado JJ. Mol Pharm. 2015 Sep 8;12(9):3194-201. doi: 10.1021/acs.molpharmaceut.5b00131. PubMed PMID: 26237401.
On the Biopharmaceutics Classification System Biowaiver of Ibuprofen García-Arieta A, Gordon J, Potthast H. J Pharm Sci. 2015 Aug;104(8):2429-32. doi:10.1002/jps.24519. PubMed PMID: 26036644.
Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid Cuesta-Gragera A, Navarro-Fontestad C, Mangas-Sanjuan V, González-Álvarez I, García-Arieta A, Trocóniz IF, Casabó VG, Bermejo M. Eur J Pharm Sci. 2015 Jul 10; 74:86-94. doi: 10.1016/j.ejps.2015.04.002. PubMed PMID: 25869458.
Evaluación económica de la restricción del uso de piroxicam en España Maciá Martínez M-Á. Reumatol Clin. 2015 Jan 27. pii: S1699-258X(14)00256-3.
Investigation on the possibility of biowaivers for ibuprofen Álvarez C, Núñez I, Torrado JJ, Gordon J, Potthast H, García-Arieta A. J Pharm Sci. 2011 Jun;100(6):2343-9.
Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies Torrado JJ, Blanco M, Farré M, Roset P, García-Arieta A. Eur J Clin Pharmacol. 2010 Jun;66(6):599-604. doi: 10.1007/s00228-010-0792-7. PMID: 20195587.
An eutomer/distomer ratio near unity does not justify non-enantiospecific assay methods in bioequivalence studies García-Arieta A, Abad-Santos F, Rodríguez-Martínez MA, Varas-Polo Y, Novalbos J, Laparidis N, Gallego-Sandín S, Orfanidis K, Torrado J. Chirality. 2005 Oct;17(8):470-5.
Trends of Non-Steroidal Anti-Inflammatory Drugs Use in Spain, 1990 through 2003 de Abajo F, García Del Pozo J, Del Pino A. Aten Primaria. 2005 Nov 15;36(8):424-33.

Validation of a semi-physiological model for caffeine in healthy subjects and cirrhotic patients Cuesta-Gragera A, Navarro-Fontestad C, Mangas-Sanjuan V, González-Álvarez I, García-Arieta A, Trocóniz IF, Casabó VG, Bermejo M. Eur J Pharm Sci. 2015 Jun 20;73:57-63. doi: 10.1016/j.ejps.2015.03.018. PubMed PMID: 25843043.
[Trends of use of anxiolytics and hypnotics in Spain from 2000 to 2011] Vicente Sánchez MP, Macías Saint-Gerons D, de la Fuente Honrubia C, GonzálezBermejo D, Montero Corominas D, Catalá-López F. Rev Esp Salud Publica. 2013 May-Jun;87(3):247-55.
Assessing bioequivalence of generic antiepilepsy drugs by indirect comparisons García Arieta A. Ann Neurol. 2012 May; 71(5):724-5; author reply 725. doi: 10.1002/ana.23583.
Interchangeability among therapeutics equivalents of lamotrigine Garcia-Arieta A, Blazquez-Perez A.Rev Neurol. 2011 Mar 1;52(5):319-20; author reply 320.
Studies in Animal Models of the Effects of Anesthetics on Behavior, Biochemistry, and Neuronal Cell Death MA Mena, J Perucho, and J Garcia de Yébenes. Journal of Alzheimer’s Disease. 2010; 22 suppl. 3: 43–S48.
Risk of upper gastrointestinal tract bleeding associated with selective serotonin reuptake inhibitors and venlafaxine therapy: interaction with nonsteroidal anti-inflammatory drugs and effect of acid-suppressing agents de Abajo FJ, García-Rodríguez LA. Arch Gen Psychiatry. 2008 Jul;65(7):795-803.
Regarding generic antiepileptic drugs García-Arieta A, Blázquez-Pérez A, de la Barrera PP, Pozo-Hernández C, Vargas-Castrillón E. Rev Neurol. 2006 Oct 1-15;43(7):446-8; author reply 448.
Antidepressants and risk of upper gastrointestinal bleeding de Abajo FJ, Montero D, Rodríguez LA, Madurga M. Basic Clin Pharmacol Toxicol. 2006 Mar;98(3):304-10. Review.
Use of antipsychotic agents in Spain through 1985-2000 Santamaría B, Pérez M, Montero D, Madurga M, de Abajo FJ. Eur Psychiatry. 2002 Dec;17(8):471-6.
Risk of upper gastrointestinal bleeding and perforation associated with low-dose aspirin as plain and enteric-coated formulations de Abajo FJ, García Rodríguez LA. BMC Clin Pharmacol. 2001;1:1. Epub 2001 Feb 13.
Antidepressant drugs: a potential new drug cause of upper gastrointestinal bleeding de Abajo FJ, García Rodríguez A, Montero D. Dig Liver Dis. 2000 Aug-Sep;32(6):455-7.
Intracranial haemorrhage and use of selective serotonin reuptake inhibitors de Abajo FJ, Jick H, Derby L, Jick S, Schmitz S. Br J Clin Pharmacol. 2000 Jul;50(1):43-7.
Association between selective serotonin reuptake inhibitors and upper gastrointestinal bleeding: population based case-control study de Abajo FJ, Rodríguez LA, Montero D. BMJ. 1999 Oct 23;319 (7217):1106-9.

One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products Prieto-Escolar M, Torrado JJ, Álvarez C, Ruiz-Picazo A, Simón-Vázquez M, Govantes C, Frias J, García-Arieta A, Gonzalez-Alvarez I, Bermejo M. One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products. Pharmaceutics. 2021 May 11;13(5):690. doi: 10.3390/pharmaceutics13050690.
Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India Lee SL, Saluja B, García-Arieta A, Santos GM, Li Y, Lu S, Hou S, Rebello J, Vaidya A, Gogtay J, Purandare S, Lyapustina S. AAPS J. 2015 Sep;17(5):1285-304. doi: 10.1208/s12248-015-9787-8. PubMed PMID: 26002510; PubMed Central PMCID: PMC4540743.
A European Perspective on Orally Inhaled Products: In Vitro Requirements for a Biowaiver García-Arieta A. J Aerosol Med Pulm Drug Deliv. 2014, 27(6): 419-429.
Equivalence Considerations for Orally Inhaled Products for Local Action-ISAM/IPAC-RS European Workshop Report Evans C, Cipolla D, Chesworth T, Agurell E, Ahrens R, Conner D, Dissanayake S, Dolovich M, Doub W, Fuglsang A, García Arieta A, Golden M, Hermann R, Hochhaus G, Holmes S, Lafferty P, Lyapustina S, Nair P, O’Connor D, Parkins D, Peterson I, Reisner C, Sandell D, Singh GJ, Weda M, Watson P. J Aerosol Med Pulm Drug Deliv. June 2012, 25(3): 117-139.
Establishing bioequivalence for orally inhaled drug products Arieta AG. Expert Opin Drug Deliv. 2011 Nov;8(11):1533-4.

Advancing rare disease treatment: EMA’s decade-long insights into engineered adoptive cell therapy for rare cancers and orphan designation. Kalland, M.E., Pose-Boirazian, T., Palomo, G.M. et al Publicado el 14 de marzo de 2024 doi.org/10.1038/s41434-024-00446-0
The European landscape for gene therapies in orphan diseases: 6-year experience with the EMA Committee for Orphan Medicinal Products Gloria M. Palomo, Tomas Pose-Boirazian, Frauke Naumann-Winter, Enrico Costa, Dinah M. Duarte, Maria E. Kalland, Eva Malikova, Darius Matusevicius, Dinko Vitezic, Kristina Larsson, Armando Magrelli, Violeta Stoyanova-Beninska, and Segundo Mariz
Challenges with advanced therapy medicinal products and how to meet them The Committee for Advanced Therapies (CAT), del que forman parte Ruiz S y Timón. M. Nat. Rev. Drug Discov. 2010; 9(3):195-201.
Use of unregulated stem-cell based medicinal products The Committee for Advanced Therapies (CAT), del que forman parte Ruiz S y Timón M. Lancet. 2010; 376:514.
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Gene transfer in corneal transplantation Hoffmann F, Timón M, Wittig B. In Progress in gene therapy research. Redberry GW ed. Nova Science Publishers, Inc. New York. 2005.
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Linaclotide for treatment of irritable bowel syndrome-the view of European regulators. Berntgen M, Enzmann H, Schabel E, Prieto Yerro C, Gómez-Outes A, Salmonson T, Musaus J. Dig Liver Dis. 2013;45(9):724-6.

Available scientific evidence on vaccine safety Picazo, JJ.; de Arístegui Fernández, J; Arteagoitia Axpe, JM.; Barranco Ordóñez, D; Barricarte Gurrea, A; Bosch José, X; Díez Domingo, J; González Romo, F; Hernández-Sampelayo Matos, T; Ruiz Contreras, J; Salleras i Sanmartí, L; Salmerón García, F; Urbiztondo Perdices, L. Vacunas 2011; 12:3-34 – vol.12 núm 01.
Genome organization and translation products of Providence virus: insight into a unique tetravirus C. T. Walter, F. M. Pringle, R. Nakayinga1, P. de Felipe, M. D. Ryan, L. A. Ball & R. A. Dorrington. J. Gen. Virology. 2010; 91: 2826-2835.
2A to the fore – Research, technology and applications G. Luke, H. Escuin, P. de Felipe & M. D. Ryan.Biotechnology and Genetic Engineering Reviews. 2009; 26:235-272.
Meeting report Virus and TSE safety forum 2008 JS Robertson, J Blümel, K Brorson, A Gröner, TR Kreil, S Ruiz, H Willkommen. Biologicals. 2009; 37(5): 345-354.
Unexpected inefficiency of the European pharmacopoeia sterility test for detecting contamination in clostridial vaccines Téllez S, Casimiro R, Vela AI, Fernández-Garayzábal JF, Ezquerra R, Latre MV, Briones V, Goyache J, Bullido R, Arboix M, Domínguez L; Vaccine 24 (2006) 1710-1715.
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Laboratory diagnosis and molecular epidemiology of an outbreak of hepatitis C virus infection among recipients of human intravenous immunoglobulin in Spain Echevarría JM, León P, Domingo CJ, López JA, Elola C, Madurga M, Salmerón F, Yap PL, Daub J, Simmonds P. Transfussion 1996, 36: 725-730.

La AEMPS: nuevas formas de comunicar y divulgar sobre ciencia en la administración pública Caballero-Garrido, Ernesto; Cañete Campos, Laura; Martin Blanco Nadia; Gracia Moneva, Belén. Publicado en el VII Congreso de Comunicación Social de la Ciencia 2019, del 9 al 11 de octubre. Burgos, España.
Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013 GBD 2013 Mortality and Causes of Death Collaborators. Lancet. 2015 Jan 10; 385(9963):117-71.
Global, regional, and national levels and causes of maternal mortality during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013 Kassebaum NJ, Bertozzi-Villa A, Coggeshall MS, Shackelford KA, Steiner C, Heuton KR, Gonzalez-Medina D, Barber R, Huynh C, Dicker D, Templin T, Wolock TM, Ozgoren AA, Abd-Allah F, Abera SF, Abubakar I, Achoki T, Adelekan A, Ademi Z, Adou AK, et al. Lancet. 2014;384(9947):980-1004.
Global, regional, and national levels of neonatal, infant, and under-5 mortality during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013 Wang H, Liddell CA, Coates MM, Mooney MD, Levitz CE, Schumacher AE, Apfel H, Iannarone M, Phillips B, Lofgren KT, Sandar L, Dorrington RE, Rakovac I, Jacobs TA, Liang X, Zhou M, Zhu J, Yang G, Wang Y, Liu S, et al. Lancet. 2014;384(9947):957-79.
[Declaration of transparency for scientific publications] Catalá-López F, Hutton B, Moher D. Med Clin (Barc). 2014 Jun 16;142(12):554-5.