Última actualización: 30 de abril de 2024
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Relación de artículos científicos escritos por o que cuentan con la participación de personal de la AEMPS.
2024
- 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
- Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology. Gómez-Outes A, Sancho-López A, Carcas Sansuan AJ, Avendaño-Solá C. Pharmacol Res. 2024 Jan;199:107045. doi: 10.1016/j.phrs.2023.107045. Epub 2023 Dec 27.PMID: 38157999
2023
- GEMA 5.3. Spanish Guideline on the Management of Asthma. Plaza Moral V, Alobid I, Álvarez Rodríguez C, Blanco Aparicio M, Ferreira J, García G, Gómez-Outes A, Garín Escrivá N, Gómez Ruiz F, Hidalgo Requena A, Korta Murua J, Molina París J, Pellegrini Belinchón FJ, Plaza Zamora J, Praena Crespo M, Quirce Gancedo S, Sanz Ortega J, Soto Campos JG. Open Respir Arch. 2023 Sep 19;5(4):100277. doi: 10.1016/j.opresp.2023.100277. eCollection 2023 Oct-Dec.PMID: 37886027
- Spanish Consensus on the Management of Chronic Rhinosinusitis With Nasal Polyps (POLIposis NAsal/POLINA 2.0). Alobid I, Colás C, Castillo JA, Arismendi E, Del Cuvillo A, Gómez-Outes A, Sastre J, Mullol J; POLINA group. J Investig Allergol Clin Immunol. 2023 Oct 16;33(5):317-331. doi: 10.18176/jiaci.0910. Epub 2023 Apr 18.PMID: 37070949
- When and How to Use Reversal Agents for Direct Oral Anticoagulants? Gómez-Outes A, Suárez-Gea ML, Lecumberri R. Curr Cardiol Rep. 2023 May;25(5):371-380. doi: 10.1007/s11886-023-01858-x. Epub 2023 Mar 28.PMID: 36976497
- 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
- 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.
2022
- Pharmacotherapy for stroke prevention in nonvalvular atrial fibrillation: current strategies and future directions. Gómez-Outes A, Suárez-Gea ML, Pérez-Cabeza AI, García-Pinilla JM. Expert Opin Pharmacother. 2022 Dec;23(17):1941-1955. doi: 10.1080/14656566.2022.2149323. Epub 2022 Nov 27.PMID: 36398362
- [Translated article] Spanish Asthma Management Guidelines (GEMA) v.5.1. Highlights and Controversies. Plaza V, Alobid I, Alvarez C, Blanco M, Ferreira J, García G, Gómez-Outes A, Gómez F, Hidalgo A, Korta J, Molina J, Pellegrini FJ, Pérez M, Plaza J, Praena M, Quirce S, Sanz J. Arch Bronconeumol. 2022 Feb;58(2):T150-T158. doi: 10.1016/j.arbres.2021.05.032. Epub 2022 Feb 14.PMID: 35971814 English, Spanish
- Spanish Asthma Management Guidelines (GEMA) VERSION 5.1. Highlights and Controversies. Plaza V, Alobid I, Alvarez C, Blanco M, Ferreira J, García G, Gómez-Outes A, Gómez F, Hidalgo A, Korta J, Molina J, Pellegrini FJ, Pérez M, Plaza J, Praena M, Quirce S, Sanz J. Arch Bronconeumol. 2022 Feb;58(2):150-158. doi: 10.1016/j.arbres.2021.05.010. Epub 2021 May 26.PMID: 34167859. English, Spanish
- Building a Healthcare Alliance for Resourceful Medicine Offensive Against Neoplasms in Hematology Added Value Framework for Hematologic Malignancies: A Comparative Analysis of Existing Tools Francesco Cerisoli, Farzad Ali, Tamás Bereczky, Natacha Bolaños, Lars Bullinger, Sujith Dhanasiri, James Gallagher, Sonia García Pérez, Jan Geissler, Yann Guillevic, Kathryn Harrison, Anastasia Naoum, Carla Portulano, Ana E Rodríguez Vicente, Renate Schulze-Rath, Gabriela Yumi Gómez, Guillermo Sanz, Jesús María Hernández Rivas
- 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.
- 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 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.
- 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.
- 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.
- 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
2021
- Reply: Preventing Bleeding With Direct-Acting Oral Anticoagulants. Gómez-Outes A, Alcubilla P, Lecumberri R, Calvo-Rojas G, Vargas-Castrillón E. J Am Coll Cardiol. 2021 Oct 19;78(16):e129. doi: 10.1016/j.jacc.2021.07.059.PMID: 34649706. No abstract available
- Meta-Analysis of Reversal Agents for Severe Bleeding Associated With Direct Oral Anticoagulants. Gómez-Outes A, Alcubilla P, Calvo-Rojas G, Terleira-Fernández AI, Suárez-Gea ML, Lecumberri R, Vargas-Castrillón E. J Am Coll Cardiol. 2021 Jun 22;77(24):2987-3001. doi: 10.1016/j.jacc.2021.04.061.PMID: 34140101
- 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.
- 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.
- 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. - 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. - 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 - 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.
2020
- Discrepancies Between GEMA and GINA in the Classification of Inhaled Corticosteroids. Plaza V, Gómez-Outes A, Quirce Gancedo S, Alobid I, Álvarez Rodríguez C, Blanco Aparicio M, García G, Gómez Ruiz F, Hidalgo Requena A, Korta Murua J, Molina París J, Pellegrini Belinchón FJ, Pérez Encinas M, Plaza Zamora J, Praena Crespo M, Sánchez Pina C, Sanz Ortega J. Arch Bronconeumol. 2020 Jul;56(7):472-473. doi: 10.1016/j.arbr.2019.10.009. Epub 2020 Apr 30.PMID: 35373761 No abstract available
- 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 - 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. - Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results. WHO Solidarity Trial Consortium The New England Journal of Medicine – 2020 Dec 2. DOI:10.1056/NEJMoa2023184
2019
- 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 - Clinical trials of advanced therapy investigational medicinal products in Spain: preparing for the European clinical trials regulation. Juan Estévez Álamo, Marcos Timón, Cristina González Gómez-Platero, Carmen Doadrio Abad, Marta Velasco González, María Yolanda de Mingo Ballesteros, María Ángeles Martín de la Sierra San Agustín & María Antonia Serrano Castro. Cell and Gene Therapy Commercial Insights – Vol 5, Issue 11 DOI: 10.18609/cgti.2019.147
- 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.
- 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.
2018
- When are the cardiovascular and stroke risks too high? Pharmacotherapy for stroke prophylaxis. Gómez-Outes A, Suárez-Gea ML, García-Pinilla JM. Expert Opin Pharmacother. 2018 Sep;19(13):1427-1440. doi: 10.1080/14656566.2018.1511703. Epub 2018 Sep 8.PMID: 30198347
- Causes of Death in Patients with Venous Thromboembolism Anticoagulated with Direct Oral Anticoagulants: A Systematic Review and Meta-Analysis. Gómez-Outes A, Terleira-Fernández AI, Lecumberri R, Suárez-Gea ML, Calvo-Rojas G, Vargas-Castrillón E. Semin Thromb Hemost. 2018 Jun;44(4):377-387. doi: 10.1055/s-0038-1642644. Epub 2018 May 3.PMID: 29723893
- EU-JAMRAI: Europe Fostering Synergies To Reduce The Burden of AMRIPC and Surveillance: AMR Control 2018 online Edition
- 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.
- 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.
2017
- Discovery methods of coagulation-inhibiting drugs. Gómez-Outes A, García-Fuentes M, Suárez-Gea ML. Expert Opin Drug Discov. 2017 Dec;12(12):1195-1205. doi: 10.1080/17460441.2017.1384811. Epub 2017 Sep 27.PMID: 28952381
- Causes of death in atrial fibrillation: Challenges and opportunities. Gómez-Outes A, Suárez-Gea ML, García-Pinilla JM. Trends Cardiovasc Med. 2017 Oct;27(7):494-503. doi: 10.1016/j.tcm.2017.05.002. Epub 2017 May 10.PMID: 28602539
- 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.
2016
- 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.
- 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.
- 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.
2015
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- On the BCS biowaivers of orally disintegrating tablets García-Arieta A, Gordon J. Eur J Pharm Sci. 2015 Jan 23; 66:107-108.
- 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.
2014
- 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.
- [Basic concepts for network meta-analysis] Catalá-López F, Tobías A, Roqué M. Aten Primaria. 2014;46(10):573-81.
- 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.
- 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].
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- [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.
- 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.
- 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.
- [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.
- [Promotion of public access and share of raw data from scientific research] Aleixandre-Benavent R, Alonso-Arroyo A, Vidal-Infer A, Catalá-López F. Med Clin (Barc). 2014;pii: S0025-7753(14)00340-6.
- [Declaration of transparency for scientific publications] Catalá-López F, Hutton B, Moher D. Med Clin (Barc). 2014 Jun 16;142(12):554-5.
- The national burden of cerebrovascular diseases in Spain: A population-based study using disability-adjusted life years Catalá-López F, Fernández de Larrea-Baz N, Morant-Ginestar C, Alvarez-Martín E, Díaz-Guzmán J, Gènova-Maleras R. Med Clin (Barc). 2014;pii: S0025-7753(14)00280-2.
- [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.
- The quality of reporting methods and results in network meta-analyses: an overview of reviews and suggestions for improvement Hutton B, Salanti G, Chaimani A, Caldwell DM, Schmid C, Thorlund K, Mills E, Catalá-López F, Turner L, Altman DG, Moher D. PLoS One. 2014;9(3):e92508.
- [Meta-analysis of randomized trials, heterogeneity and prediction intervals] Catalá-López F, Tobías A. Med Clin (Barc). 2014;142(6):270-4.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
2013
- Cosméticos para niños menores de tres años. Evaluación de la seguridad Sánchez León RC. Industria farmacéutica. 2013 Ene-Feb; (175):46-49.
- La frontera en productos sanitarios Abad Luna MC. Industria farmacéutica. 2013 Ene-Feb; (175):30-35.
- [Regulatory procedures of non-interventional post-authorization studies in Spain] Vicente Sánchez MP, González Bermejo D, Macías Saint-Gerons D, de la Fuente Honrubia C. Farm Hosp. 2013;37(6):530-533.
- 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.
- [Ethical and methodological quality of non-interventional post-authorization studies promoted by Hospital Pharmacy Departments] González Bermejo D, Vicente Sánchez MP, Pozuelo González C, Macías Saint-Gerons D, Greciano Greciano V, de la Fuente Honrubia C. Farm Hosp. 2013 Nov-Dec;37(6):482-8.
- [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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Condiciones de uso armonizadas y actualizadas de la 18F-fluodesoxiglucosa en Europa Cortés-Blanco, A.; Martínez-Lázaro, R.; (16 de abril de 2013). Alasbimn Journal, ISSN: 0717 – 4055.
2012
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- [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.
- 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.
- 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.
- Reasons to Use Stereoselective Assay Methods Garcia Arieta A. Chirality. 2012 Apr 23. doi: 10.1002/chir.22022.
- 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.
- 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.
2011
- Establishing bioequivalence for orally inhaled drug products Arieta AG. Expert Opin Drug Deliv. 2011 Nov;8(11):1533-4.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
2010
- 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.
- 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.
- [Non-interventional post-authorisation studies in Spain: impact of the 2002 regulation] De la Fuente C, Macías D, Vargas E, De Abajo FJ. Med Clin (Barc). 2010; 135: 423–7.
- [Non-interventional post-authorisation studies in Spain: justification and basis of a new regulation] De la Fuente C, de Abajo FJ, García J, Vargas E. Med Clin (Barc). 2010; 134:605–11.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
2009
-
- Apixaban or enoxaparin for thromboprophylaxis. Gómez-Outes A, Suárez-Gea ML, Pozo-Hernández C. N Engl J Med. 2009;361(21):2100-1.
- Uso compasivo de medicamentos: un cambio necesario en España Avendaño C. Med Clin (Barc). 2009;133(11):425–426.
- 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.
- 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.
- New anticoagulants: focus on venous thromboembolism Gómez-Outes A, Lecumberri R, Pozo C, Rocha E. Curr Vasc Pharmacol. 2009 Jul;7(3):309-29
- 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.
- Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence Tothfalusi L, Endrenyi L, Arieta AG. Clin Pharmacokinet. 2009;48(11):725-43.
- Computer simulations of bioequivalence trials: selection of design and analyte in BCS drugs with first-pass hepatic metabolism: Part II. Non-linear kinetics Fernández-Teruel C, Gonzalez-Alvarez I, Navarro-Fontestad C, García-Arieta A, Bermejo M, Casabó VG. Eur J Pharm Sci. 2009 Jan 31;36(1):147-56.
- Computer simulations of bioequivalence trials: selection of design and analyte in BCS drugs with first-pass hepatic metabolism: linear kinetics (I) Fernández-Teruel C, Nalda Molina R, González-Alvarez I, Navarro-Fontestad C, García-Arieta A, Casabó VG, Bermejo M. Eur J Pharm Sci. 2009 Jan 31;36(1):137-46.
- Fe de erratas en Seguridad Nuclear 2004:31:51.
- 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.
2008
- Condiciones de uso humano autorizadas en la práctica clínica para los radiofármacos compuestos de iobenguano (123I) comercializados en España Cortés-Blanco A, Martínez Lázaro R, Vargas Castrillón E. Rev Esp Med Nucl. 2008; 27(6):468-74.
- Participación de las mujeres en los Ensayos Clínicos según los informes de la Agencia Española de Medicamentos y Productos Sanitarios. 2007 Noa Laguna Goya y Fernando de Andrés Rodríguez-Trelles. Rev Esp Salud Pública 2008; 82: 343-350.
- 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.
2007
- Radiofármacos PET de uso humano en España: pasado y presente Cortés-Blanco A. Seguridad Nuclear 2007;42:28-35.
- Contribución al libro “La gripe aviar, ¿una nueva amenaza pandémica?” A. Portela y otros autores. Editado por el CSIC, 2007. Coordinado por J. Ortín.
- Bases regulatorias de los medicamentos de origen biotecnológico Timón M, Ruiz S. Revista Española de Economía de la Salud. 2007; 6 (6): 346-351.
2006
- 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.
- 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.
- Regulation about generics approval Laguna-Goya N, Blázquez-Pérez A, Pozo-Hernández C. Farm Hosp. 2006 Nov-Dec;30(6):379-84. Review. Spanish.
- 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.
- 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.
- 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.
- 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.
- Contribución en el libro “Biotecnología en la Medicina del Futuro” A. Portela, y otros autores. Editado por la Fundación COTEC para la “Innovación Tecnológica” 2006.
- Orthomyxoviridae, capitulo 18 del libro “Virus Patógenos” A. Portela y J. Ortín. Libro editado por Editorial Hélice, 2006.
- E UNUM PLURIBUS: multiple proteins from a self-processing polyprotein P. de Felipe, G. A. Luke, L. E. Hughes, C. Halpin & M. D. Ryan. Trends in Biotechnology 2006, 24:68-75.
2005
- 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.
- 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.
- Contribución al libro “Conferencia consenso sobre gripe” A Pórtela, F Salmerón y otros autores. Asociación Española de Vacunología, 2005.
- 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.
2004
- Reglamento de productos cosméticos. Notificación de efectos graves no deseados Sánchez León R.C, Moreno Luquero M, Abad Luna M.C. NCP, 2014.; Marzo-Abril 2014 (336):5-8.
- 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.
- Acute and clinically relevant drug-induced liver injury: a population based case-control study de Abajo FJ, Montero D, Madurga M, García Rodríguez LA. Br J Clin Pharmacol. 2004 Jul;58(1):71-80.
- Analysis of invasive Haemophilus influenzae infections after extensive vaccination against H. influenzae type b Campos J, Hernando M, Román F, Pérez-Vázquez M, Aracil B, Oteo J, Lázaro E, de Abajo F; Group of Invasive Haemophilus Infections of the Autonomous Community of Madrid, Spain,. J Clin Microbiol. 2004 Feb;42(2):524-9.
- 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.
- External quality assessment for the detection of blood-borne viruses in plasma by nucleic acid amplification technology: the first human immunodeficiency virus and hepatitis B virus studies (HIV EQA/1 and HBV EQA/1) and the fifth hepatitis C virus study (HCV EQA/5) G. Pisani, K. Cristiano, J. Saldanha, M. Wirz, G.M. Bisso, C. Mele, G. Gentili, and EQA Participants (A . Portela y otros autores).1: Vox Sang. 87(2):91-5, 2004.
- Mecanismos de acción de los diferentes tipos de vacuna F Salmerón. En la monografía de la Sociedad Española de Epidemiología: “Epidemiología de las Enfermedades Incluidas en un Programa de Vacunación” pg 17, 2004.
2003
- La frontera en productos sanitarios Abad Luna M.C. Industria farmacéutica, 2013. Enero-Febrero 2013 (175):30-35.
- Cosméticos para niños menores de tres años. Evaluación de la seguridad Sánchez León R.C. Industria farmacéutica, 2013. Enero-Febrero 2013 (175):46-49.
- 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.
2002
- The BIFAP project: database for pharmaco-epidemiological research in primary care Salvador Rosa A, Moreno Pérez JC, Sonego D, García Rodríguez LA, de Abajo Iglesias FJ. Aten Primaria. 2002 Dec;30(10):655-61.
- 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.
- 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).
- [Laboratory diagnosis of pertussis. Role of serology] Sanz Moreno JC, De Ory Manchón F, González Alonso J, de La Torre JL, Salmerón F, Limia A, Tello O, Pachón I, Amela C, Vázquez J, de Ory F, Sanz JC; Grupo de Trabajo sobre Tos Ferina. Enferm Infecc Microbiol Clin. 2002 May; 20(5):212-8.
2001
- 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.
- 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.
2000
- 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.
- 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.
- 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.
- 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.
1999
- What are we talking about? Ruiz, M.S. Biotechnological Products and Gene Therapy. Methods and Findings in Experimental and Clinical Pharmacology 1999, 21, suppl.B: 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.
1998
- 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.
1997
- Influenza vaccination in 22 developed countries: an update to 1995 Fedson DS, Hirota Y, Shin HK, Cambillard PE, Kiely J, Ambrosch F, Hannoun C, Leese J, Sprenger MJ, Hampson AW, Bro-Jørgensen K, Ahlbom AM, Nøkleby H, Valle M, Olafsson O, Salmerón F, Cloetta J, Rebelo de Andrade H, Snacken R, Donatelli I, Jennings LC, Strikas RA. Vaccine. 1997; 15(14):1506-11.
1996
- 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.
- 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.
1992
- Primary immunodeficiency caused by mutations in the gene encoding the CD3? subunit of the T-lymphocyte receptor Arnaiz-Villena A, Timón M, Corell A, Pérez-Aciego P, Martín-Villa JM, Regueiro JR. N. Engl. J. Med. 1992; 327:529-533.