@article{3020938, title = "Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases", author = "Sheean, M.E. and Malikova, E. and Duarte, D. and Capovilla, G. and Fregonese, L. and Hofer, M.P. and Magrelli, A. and Mariz, S. and Mendez-Hermida, F. and Nistico, R. and Leest, T. and Sipsas, N.V. and Tsigkos, S. and Vitezic, D. and Larsson, K. and Sepodes, B. and Stoyanova-Beninska, V.", journal = "Drug Discovery Today", year = "2020", volume = "25", number = "2", pages = "274-291", publisher = "Elsevier Ireland Ltd", issn = "1359-6446", doi = "10.1016/j.drudis.2019.10.015", keywords = "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", abstract = "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" }