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Literature DB >> 31704277

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

Maria E Sheean¹, Eva Malikova², Dinah Duarte³, Giuseppe Capovilla⁴, Laura Fregonese⁵, Matthias P Hofer⁵, Armando Magrelli⁶, Segundo Mariz⁵, Fernando Mendez-Hermida⁷, Robert Nistico⁸, Tim Leest⁹, Nikolaos V Sipsas¹⁰, Stelios Tsigkos⁵, Dinko Vitezic¹¹, Kristina Larsson⁵, Bruno Sepodes¹², Violeta Stoyanova-Beninska¹³.

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.

Entities: Disease

Mesh：

Year: 2019 PMID： 31704277 DOI： 10.1016/j.drudis.2019.10.015

Source DB: PubMed Journal: Drug Discov Today ISSN： 1359-6446 Impact factor: 7.851

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Cited

1 in total

Review 1. Regulatory Standards in Orphan Medicinal Product Designation in the EU.

Authors: Stelios Tsigkos; Segundo Mariz; Maria Elzbieta Sheean; Kristina Larsson; Armando Magrelli; Violeta Stoyanova-Beninska
Journal: Front Med (Lausanne) Date: 2021-06-25

1 in total