Pretraga

Pretražite po imenu i prezimenu autora, mentora, urednika, prevoditelja

Napredna pretraga

Pregled bibliografske jedinice broj: 1055462

Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases

Sheean, Maria E.; Malikova, Eva; Duarte, Dinah; Capovilla, Giuseppe; Fregonese, Laura; Hofer, Matthias P.; Magrelli, Armando; Mariz, Segundo; Mendez-Hermida, Fernando; Nistico, Robert et al.
Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases // Drug discovery today, 25 (2020), 2; 274-291 doi:10.1016/j.drudis.2019.10.015 (međunarodna recenzija, pregledni rad, znanstveni)

CROSBI ID: 1055462 Za ispravke kontaktirajte CROSBI podršku putem web obrasca

Naslov
Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases

Autori
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

Izvornik
Drug discovery today (1359-6446) 25 (2020), 2; 274-291

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, pregledni rad, znanstveni

Ključne riječi
monkeypox virus-infection ; nonhuman primate models ; influenza-a virus ; animal-models ; bacillus-anthracis ; avian influenza ; in-vitro ; visceral leishmaniasis ; cynomolgus macaques ; h5n1 virus

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Temeljne medicinske znanosti



POVEZANOST RADA

Ustanove:
Medicinski fakultet, Rijeka

Profili:

Avatar Url Dinko Vitezić (autor)

Poveznice na cjeloviti tekst rada:

doi www.sciencedirect.com

Citiraj ovu publikaciju:

Sheean, Maria E.; Malikova, Eva; Duarte, Dinah; Capovilla, Giuseppe; Fregonese, Laura; Hofer, Matthias P.; Magrelli, Armando; Mariz, Segundo; Mendez-Hermida, Fernando; Nistico, Robert et al.
Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases // Drug discovery today, 25 (2020), 2; 274-291 doi:10.1016/j.drudis.2019.10.015 (međunarodna recenzija, pregledni rad, znanstveni)
Sheean, M., Malikova, E., Duarte, D., Capovilla, G., Fregonese, L., Hofer, M., Magrelli, A., Mariz, S., Mendez-Hermida, F. & Nistico, R. (2020) Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases. Drug discovery today, 25 (2), 274-291 doi:10.1016/j.drudis.2019.10.015.
@article{article, author = {Sheean, Maria E. and Malikova, Eva and Duarte, Dinah and Capovilla, Giuseppe and Fregonese, Laura and Hofer, Matthias P. and Magrelli, Armando and Mariz, Segundo and Mendez-Hermida, Fernando and Nistico, Robert and Leest, Tim and Sipsas, Nikolaos V. and Tsigkos, Stelios and Vitezic, Dinko and Larsson, Kristina and Sepodes, Bruno and Stoyanova-Beninska, Violeta}, year = {2020}, pages = {274-291}, DOI = {10.1016/j.drudis.2019.10.015}, keywords = {monkeypox virus-infection, nonhuman primate models, influenza-a virus, animal-models, bacillus-anthracis, avian influenza, in-vitro, visceral leishmaniasis, cynomolgus macaques, h5n1 virus}, journal = {Drug discovery today}, doi = {10.1016/j.drudis.2019.10.015}, volume = {25}, number = {2}, issn = {1359-6446}, title = {Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases}, keyword = {monkeypox virus-infection, nonhuman primate models, influenza-a virus, animal-models, bacillus-anthracis, avian influenza, in-vitro, visceral leishmaniasis, cynomolgus macaques, h5n1 virus} }
@article{article, author = {Sheean, Maria E. and Malikova, Eva and Duarte, Dinah and Capovilla, Giuseppe and Fregonese, Laura and Hofer, Matthias P. and Magrelli, Armando and Mariz, Segundo and Mendez-Hermida, Fernando and Nistico, Robert and Leest, Tim and Sipsas, Nikolaos V. and Tsigkos, Stelios and Vitezic, Dinko and Larsson, Kristina and Sepodes, Bruno and Stoyanova-Beninska, Violeta}, year = {2020}, pages = {274-291}, DOI = {10.1016/j.drudis.2019.10.015}, keywords = {monkeypox virus-infection, nonhuman primate models, influenza-a virus, animal-models, bacillus-anthracis, avian influenza, in-vitro, visceral leishmaniasis, cynomolgus macaques, h5n1 virus}, journal = {Drug discovery today}, doi = {10.1016/j.drudis.2019.10.015}, volume = {25}, number = {2}, issn = {1359-6446}, title = {Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases}, keyword = {monkeypox virus-infection, nonhuman primate models, influenza-a virus, animal-models, bacillus-anthracis, avian influenza, in-vitro, visceral leishmaniasis, cynomolgus macaques, h5n1 virus} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE

Citati:

    Altmetrijski pokazatelji:


    Podijeli:





    Contrast
    Increase Font
    Decrease Font
    Dyslexic Font
    CROSBI koristi kolačiće (cookies) kako bi poboljšao funkcionalnost stranice.