Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases (CROSBI ID 276692)
Prilog u časopisu | pregledni rad (znanstveni) | međunarodna recenzija
Podaci o odgovornosti
Sheean, Maria E. ; Malikova, Eva ; Duarte, Dinah ; Capovilla, Giuseppe ; Fregonese, Laura ; Hofer, Matthias P. ; Magrelli, Armando ; Mariz, Segundo ; Mendez-Hermida, Fernando ; Nistico, Robert ; Leest, Tim ; Sipsas, Nikolaos V. ; Tsigkos, Stelios ; Vitezic, Dinko ; Larsson, Kristina ; Sepodes, Bruno ; Stoyanova-Beninska, Violeta
engleski
Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases
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 in the European Union (EU). In this review, we provide transparency regarding assessment criteria and an in-depth review of nonclinical models and data that have been used to support OMPDs. Additionally, we present a literature-based analysis of existing nonclinical models and discuss key features of nonclinical studies, which are considered crucial for the support of future OMPDs. This could not only inform future drug development in rare infectious conditions, but also indicate areas where nonclinical models are indispensable or can be made more efficient.
monkeypox virus-infection ; nonhuman primate models ; influenza-a virus ; animal-models ; bacillus-anthracis ; avian influenza ; in-vitro ; visceral leishmaniasis ; cynomolgus macaques ; h5n1 virus
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Podaci o izdanju
25 (2)
2020.
274-291
objavljeno
1359-6446
1878-5832
10.1016/j.drudis.2019.10.015
Povezanost rada
Temeljne medicinske znanosti