Zobrazeno 1 - 10 of 10 pro vyhledávání: '"Dinah Duarte"'
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Akademický článek
Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations
Autor: Carla Pires, Dinah Duarte, Afonso Cavaco
Publikováno v: Acta Médica Portuguesa, Vol 34, Iss 3 (2021)
Introduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify th
Externí odkaz: https://doaj.org/article/add1efa1b0994d498f0c37e3d7459d8f
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3
Safety signals assessed by the pharmacovigilance risk assessement committee: biologics vs conventional medicines
Autor: Margarida Estudante, Teresa Lopes, Dinah Duarte
Publikováno v: Journal Biomedical and Biopharmaceutical Research (BBR), Vol 16, Iss 1, Pp 202-212 (2019)
The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for medicines safety monitoring in Europe. Biologic drugs (BDs) have more recently been developed and reinforced the treatment of serious and chronic diseases. Because of their spe
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doajarticles::a8ea04594a8f1437d744a5ea71c924a4
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4
A Regulatory and Safety Perspective on Medical Devices
Autor: Carla Pires, Dinah Duarte
In the European Union (EU), medical devices (MD) industry is a representative employer, with the MD sales accounting for EUR 100 billion. This chapter presents the classification and give some examples of MD in EU and describes and analyzes all safet
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::f98835e9a4258211d0ae80a579d405d2
https://doi.org/10.4018/978-1-7998-3479-3.ch125
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5
Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations
Autor: Carla Pires, Dinah Duarte, Afonso Cavaco
Publikováno v: Acta Médica Portuguesa; v. 34, n. 3 (2021): Março; 201-208
Repositório Científico de Acesso Aberto de Portugal
Repositório Científico de Acesso Aberto de Portugal (RCAAP)
instacron:RCAAP
Acta Médica Portuguesa, Vol 34, Iss 3, Pp 201-208 (2021)
Introduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify th
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::505be805456f27be1e5f1c22e310805e
https://pubmed.ncbi.nlm.nih.gov/33971115
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6
Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases
Autor: Segundo Mariz, Fernando Mendez-Hermida, Violeta Stoyanova-Beninska, Maria E. Sheean, Laura Fregonese, Dinko Vitezić, Armando Magrelli, Nikolaos V. Sipsas, Tim Leest, Stelios Tsigkos, Dinah Duarte, Bruno Sepodes, Eva Malikova, Robert Nistico, Giuseppe Capovilla, Matthias P. Hofer, Kristina Larsson
Publikováno v: Drug Discovery Today
Volume 25
Issue 2
The Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) is responsible for evaluating applications for orphan designation (OMPDs) and for deciding the orphan status at the time of marketing authorization of medicines
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e58e9b1e4b49f0c050ffbef7f5ce2103
http://hdl.handle.net/2108/227456
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7
Evaluation of Juvenile Animal Studies for Pediatric CNS-Targeted Compounds: A Regulatory Perspective
Autor: Jan Willem van der Laan, Nico C B de Jager, Cláudio Gouveia Roque, Isabel Vieira, Jacqueline Carleer, Karen van Malderen, Dinah Duarte, Fabien Lavergne, Lutz Wiesner, Gunter F. Egger
Publikováno v: International Journal of Toxicology. SAGE Publications Inc.
Central nervous system (CNS)-targeted products are an important category of pediatric pharmaceuticals. In view of the significant postnatal maturation of the CNS, juvenile animal studies (JAS) are performed to support pediatric development of these n
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::772751dcdf430b1d2b9540c59ad95ea5
https://pubmed.ncbi.nlm.nih.gov/31662008
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8
The translational value of animal models in orphan medicines designations for rare paediatric neurological diseases
Autor: Dinah Duarte, Maria Beatriz da Silva Lima, Bruno Sepodes
Publikováno v: Regulatory Toxicology and Pharmacology. 118:104810
Rare diseases are characterized by a substantial unmet need mostly because the majority have limited, or no treatment options and a large number also affect children. Appropriate animal models, based on the knowledge of the molecular pathology of the
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::accf24c87a994811a0267c35870857c5
https://doi.org/10.1016/j.yrtph.2020.104810
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Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
Autor: Dinah Duarte, Susana Perez-Gutthann, Maria Teresa Herdeiro
Publikováno v: Pharmacoepidemiology and Drug Safety
Repositório Científico de Acesso Aberto de Portugal
Repositório Científico de Acesso Aberto de Portugal (RCAAP)
instacron:RCAAP
Submitted by Maria Herdeiro (teresaherdeiro@ua.pt) on 2021-03-24T18:50:19Z No. of bitstreams: 1 artigo.pdf: 1083376 bytes, checksum: 4caa67206f2069b31fe57b72aadfa71b (MD5) Approved for entry into archive by Diana Silva (dianasilva@ua.pt) on 2021-03-2
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::278b752666c61569bd5a64299f2cb714
https://pubmed.ncbi.nlm.nih.gov/29327451
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10
Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions
Autor: Michel Hoffmann, Matthias P. Hofer, Kristina Larsson, Violeta Stoyanova-Beninska, Milton Bonelli, Evyenia Shaili, Maria E. Sheean, Mario Ricciardi, Giuseppe Capovilla, Bruno Sepodes, Dinah Duarte, Armando Magrelli, Stelios Tsigkos, Benedetta Polsinelli, Pavel Balabanov, Segundo Mariz
Publikováno v: Drug discovery today. 23(1)
Here, we provide an in-depth literature and experience-based review of nonclinical models and data used to support orphan medicinal product designations (OMPDs) in rare neurodegenerative conditions. The Committee for Orphan Medicinal Products (COMP)
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::51a1b89674041488458c13bc8b928ced
https://pubmed.ncbi.nlm.nih.gov/28987289
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