Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases.,Drug Discovery Today

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Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases.
Drug Discovery Today ( IF 6.5 ) Pub Date : 2019-11-05 , DOI: 10.1016/j.drudis.2019.10.015
Maria E Sheean ₁ , Eva Malikova ₂ , Dinah Duarte ₃ , Giuseppe Capovilla ₄ , Laura Fregonese ₅ , Matthias P Hofer ₅ , Armando Magrelli ₆ , Segundo Mariz ₅ , Fernando Mendez-Hermida ₇ , Robert Nistico ₈ , Tim Leest ₉ , Nikolaos V Sipsas ₁₀ , Stelios Tsigkos ₅ , Dinko Vitezic ₁₁ , Kristina Larsson ₅ , Bruno Sepodes ₁₂ , Violeta Stoyanova-Beninska ₁₃

Affiliation

Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands; Max-Delbrück Center for Molecular Medicine in Helmholz Association, Berlin, Germany.
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.
Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; INFARMED - Autoridade Nacional do Medicamento, Lisbon, Portugal.
Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; C. Poma Hospital, Mantova, Italy; Fondazione Poliambulanza, Brescia, Italy.
Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy.
Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Malta Medicines Authority, San Ġwann, Malta.
Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; The Federal Agency for Medicines and Health Products, Brussels, Belgium.
Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Medical School, National and Kapodistrian University of Athens, Athens, Greece.
Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; University of Rijeka Medical School and University Hospital Centre Rijeka, Rijeka, Croatia.
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.
Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands.

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.

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