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

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.

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

Authors: M.E. Sheean 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.
Publication date: 1 January 2020
Publisher

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 Author

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