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

Animals Communicable Diseases / drug therapy Humans Neglected Diseases / drug therapy Orphan Drug Production Rare Diseases / drug therapy

Journal

Drug discovery today
ISSN: 1878-5832
Titre abrégé: Drug Discov Today
Pays: England
ID NLM: 9604391

Informations de publication

Date de publication:
02 2020
Historique:
received: 26 07 2019
revised: 15 10 2019
accepted: 30 10 2019
pubmed: 11 11 2019
medline: 1 5 2021
entrez: 10 11 2019
Statut: ppublish

Résumé

This review provides an overview of nonclinical in vivo models that can be used to support orphan designation in selected rare infectious diseases in Europe, with the aim to inform and stimulate the planning of nonclinical development in this area of often neglected diseases.

Identifiants

DOI: 10.1016/j.drudis.2019.10.015 PMID: 31704277
pubmed: 31704277
pii: S1359-6446(19)30419-2
doi: 10.1016/j.drudis.2019.10.015
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

274-291

Informations de copyright

Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

Maria E Sheean (ME)

Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands; Max-Delbrück Center for Molecular Medicine in Helmholz Association, Berlin, Germany. Electronic address: maria.sheean@ema.europa.eu.

Eva Malikova (E)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; State Institute for Drug Control, Bratislava, Slovak Republic; Comenius University, Department of Pharmacology and Toxicology, Bratislava, Slovak Republic.

Dinah Duarte (D)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; INFARMED - Autoridade Nacional do Medicamento, Lisbon, Portugal.

Giuseppe Capovilla (G)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; C. Poma Hospital, Mantova, Italy; Fondazione Poliambulanza, Brescia, Italy.

Laura Fregonese (L)

Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.

Matthias P Hofer (MP)

Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.

Armando Magrelli (A)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy.

Segundo Mariz (S)

Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.

Fernando Mendez-Hermida (F)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.

Robert Nistico (R)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Malta Medicines Authority, San Ġwann, Malta.

Tim Leest (T)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; The Federal Agency for Medicines and Health Products, Brussels, Belgium.

Nikolaos V Sipsas (NV)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Medical School, National and Kapodistrian University of Athens, Athens, Greece.

Stelios Tsigkos (S)

Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.

Dinko Vitezic (D)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; University of Rijeka Medical School and University Hospital Centre Rijeka, Rijeka, Croatia.

Kristina Larsson (K)

Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.

Bruno Sepodes (B)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; INFARMED - Autoridade Nacional do Medicamento, Lisbon, Portugal; Universidade de Lisboa - Faculdade de Farmácia, Lisbon, Portugal.

Violeta Stoyanova-Beninska (V)

Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Nonclinical data supporting orphan medicinal...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Caractéristiques de la maladie › Maladies transmissibles › Nonclinical data supporting orphan medicinal...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Nonclinical data supporting orphan medicinal...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Caractéristiques de la maladie › Maladies négligées › Nonclinical data supporting orphan medicinal...
questionsmedicales.fr › Technologie, industrie et agriculture › Industrie › Secteur secondaire › Industrie pharmaceutique › Médicament orphelin › Nonclinical data supporting orphan medicinal...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Caractéristiques de la maladie › Maladies rares › Nonclinical data supporting orphan medicinal...