TY - JOUR
TI - Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases
AU - Sheean, M.E.
AU - Malikova, E.
AU - Duarte, D.
AU - Capovilla, G.
AU - Fregonese, L.
AU - Hofer, M.P.
AU - Magrelli, A.
AU - Mariz, S.
AU - Mendez-Hermida, F.
AU - Nistico, R.
AU - Leest, T.
AU - Sipsas, N.V.
AU - Tsigkos, S.
AU - Vitezic, D.
AU - Larsson, K.
AU - Sepodes, B.
AU - Stoyanova-Beninska, V.
JO - Drug Discovery Today
PY - 2020
VL - 25
TODO - 2
SP - 274-291
PB - Elsevier Ireland Ltd
SN - 1359-6446
TODO - 10.1016/j.drudis.2019.10.015
TODO - orphan drug, Acanthamoeba keratitis;  anthrax;  avian influenza;  clinical assessment;  cystic fibrosis;  drug efficacy;  drug legislation;  Ebola hemorrhagic fever;  evidence based medicine;  human;  infection;  leishmaniasis;  malaria;  mucormycosis;  nonhuman;  Orthopoxvirus;  rare disease;  Review;  smallpox;  tuberculosis;  animal;  communicable disease;  drug manufacture;  neglected disease;  rare disease, Animals;  Communicable Diseases;  Humans;  Neglected Diseases;  Orphan Drug Production;  Rare Diseases
TODO - 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. © 2019 The Authors
ER -