Nonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditions

Author:

Sheean Maria E.,Stoyanova-Beninska Violeta,Capovilla Giuseppe,Duarte Dinah,Hofer Matthias P.,Hoffmann Michel,Magrelli Armando,Mariz Segundo,Tsigkos Stelios,Shaili Evyenia,Polsinelli Benedetta,Ricciardi Mario,Bonelli Milton,Balabanov Pavel,Larsson Kristina,Sepodes Bruno

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference164 articles.

1. Animal models for metabolic, neuromuscular and ophthalmological rare diseases;Vaquer;Nat. Rev. Drug Discov.,2013

2. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products;European Commission,1999

3. Guideline on the Format and Content of Applications for Designation as Orphan Medicinal Products and on the Transfer of Designations from One Sponsor to Another;European Commission,2014

4. Worldwide collaboration for orphan drug designation;Mariz;Nat. Rev. Drug Discov.,2016

5. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the Protection of Animals Used for Scientific Purposes;European Commission,2010

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