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Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases.
Sheean, Maria E; Malikova, Eva; Duarte, Dinah; Capovilla, Giuseppe; Fregonese, Laura; Hofer, Matthias P; Magrelli, Armando; Mariz, Segundo; Mendez-Hermida, Fernando; Nistico, Robert; Leest, Tim; Sipsas, Nikolaos V; Tsigkos, Stelios; Vitezic, Dinko; Larsson, Kristina; Sepodes, Bruno; Stoyanova-Beninska, Violeta.
Affiliation
  • Sheean ME; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands; Max-Delbrück Center for Molecular Medicine in Helmholz Association, Berlin, Germany. Electronic address: maria.sheean@ema.europa.eu.
  • Malikova E; 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.
  • Duarte D; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; INFARMED - Autoridade Nacional do Medicamento, Lisbon, Portugal.
  • Capovilla G; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; C. Poma Hospital, Mantova, Italy; Fondazione Poliambulanza, Brescia, Italy.
  • Fregonese L; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
  • Hofer MP; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
  • Magrelli A; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Rome, Italy.
  • Mariz S; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
  • Mendez-Hermida F; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
  • Nistico R; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Malta Medicines Authority, San Gwann, Malta.
  • Leest T; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; The Federal Agency for Medicines and Health Products, Brussels, Belgium.
  • Sipsas NV; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Medical School, National and Kapodistrian University of Athens, Athens, Greece.
  • Tsigkos S; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
  • Vitezic D; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; University of Rijeka Medical School and University Hospital Centre Rijeka, Rijeka, Croatia.
  • Larsson K; Orphan Medicines Office, European Medicines Agency, Amsterdam, The Netherlands.
  • Sepodes B; 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.
  • Stoyanova-Beninska V; Committee of Orphan Medicinal Products, European Medicines Agency, Amsterdam, The Netherlands; Medicines Evaluation Board, Utrecht, The Netherlands.
Drug Discov Today ; 25(2): 274-291, 2020 02.
Article in En | MEDLINE | ID: mdl-31704277
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Orphan Drug Production / Communicable Diseases / Rare Diseases / Neglected Diseases Limits: Animals / Humans Language: En Journal: Drug Discov Today Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2020 Document type: Article
Fulltext
Add to My VHL
Print
XML
PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Orphan Drug Production / Communicable Diseases / Rare Diseases / Neglected Diseases Limits: Animals / Humans Language: En Journal: Drug Discov Today Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2020 Document type: Article