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Marketing authorisation of orphan medicines in Europe from 2000 to 2013.
Hofer, Matthias P; Hedman, Hanna; Mavris, Maria; Koenig, Franz; Vetter, Thorsten; Posch, Martin; Vamvakas, Spiros; Regnstrom, Jan; Aarum, Stiina.
Afiliação
  • Hofer MP; European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5 EU, UK.
  • Hedman H; European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5 EU, UK.
  • Mavris M; European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5 EU, UK.
  • Koenig F; Center for Medical Statistics, Informatics, and Intelligent Systems, Section for Medical Statistics, Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austria.
  • Vetter T; European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5 EU, UK.
  • Posch M; Center for Medical Statistics, Informatics, and Intelligent Systems, Section for Medical Statistics, Medical University Vienna, Spitalgasse 23, 1090 Vienna, Austria.
  • Vamvakas S; European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5 EU, UK.
  • Regnstrom J; European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5 EU, UK.
  • Aarum S; European Medicines Agency, 30 Churchill Place, Canary Wharf, London E14 5 EU, UK. Electronic address: Stiina.Aarum@ema.europa.eu.
Drug Discov Today ; 23(2): 424-433, 2018 02.
Article em En | MEDLINE | ID: mdl-29074441
ABSTRACT
An analysis was performed on a data set of 157 orphan designated medicines with an outcome for marketing authorisation application (MAA) between 2000 and 2013. The intention was to understand the factors associated with marketing authorisation success, the challenges developers face regarding orphan medicine development, and how scientific advice (SA) is used during development. The results demonstrated that orphan medicines have a lower success rate compared with non-orphan medicines and that determinants for marketing authorisation success were company size and compliance with SA. Compliance with SA could help orphan medicine developers overcome clinical development challenges.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produção de Droga sem Interesse Comercial / Marketing Limite: Humans País/Região como assunto: Europa Idioma: En Revista: Drug Discov Today Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Reino Unido
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produção de Droga sem Interesse Comercial / Marketing Limite: Humans País/Região como assunto: Europa Idioma: En Revista: Drug Discov Today Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2018 Tipo de documento: Article País de afiliação: Reino Unido