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

Maria E Sheean, Eva Malikova, Dinah Duarte, Giuseppe Capovilla, Laura Fregonese, Matthias P Hofer, Armando Magrelli, Segundo Mariz, Fernando Mendez-Hermida, Robert Nistico, Tim Leest, Nikolaos V Sipsas, Stelios Tsigkos, Dinko Vitezic, Kristina Larsson, Bruno Sepodes, Violeta Stoyanova-Beninska

Research output: Contribution to journalReview article

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.

Original languageEnglish
Pages (from-to)274-291
Number of pages18
JournalDrug Discovery Today
Volume25
Issue number2
DOIs
Publication statusPublished - Feb 2020

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    Sheean, M. E., Malikova, E., Duarte, D., Capovilla, G., Fregonese, L., Hofer, M. P., Magrelli, A., Mariz, S., Mendez-Hermida, F., Nistico, R., Leest, T., Sipsas, N. V., Tsigkos, S., Vitezic, D., Larsson, K., Sepodes, B., & Stoyanova-Beninska, V. (2020). Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases. Drug Discovery Today, 25(2), 274-291. https://doi.org/10.1016/j.drudis.2019.10.015