Orphan drugs, orphan diseases. The first decade of orphan drug legislation in the EU
- Author
- JOPPI, Roberta2 ; BERTELE, Vittorio1 ; GARATTINI, Silvio1
[1] Laboratory of Drug Regulatory Policies, Mario Negri Institute for Pharmacological Research, Via Giuseppe La Masa, 19, 20156 Milan, Italy
[2] Pharmaceutical Department, Local Health Unit of Verona, Via Salvo D'Acquisto 7, 37122 Verona, Italy - Source
European journal of clinical pharmacology. 2013, Vol 69, Num 4, pp 1009-1024, 16 p ; ref : 20 ref
- ISSN
- 0031-6970
- Scientific domain
- Pharmacology drugs
- Publisher
- Springer, Heidelberg
- Publication country
- Germany
- Document type
- Article
- Language
- English
- Author keyword
- Clinical efficacy Clinical trials Development Drug regulation Orphan drug Outcome measures Pharmacological research Placebo Preclinical studies Rare disease
- Keyword (fr)
- Efficacité traitement Essai clinique Essai préclinique Homme Législation Médicament orphelin Placebo Pronostic Recherche et développement Santé publique Maladie orpheline Maladie rare Europe
- Keyword (en)
- Treatment efficiency Clinical trial Preclinical trial Human Legislation Orphan drug Placebo Prognosis Research and development Public health Orphan disease Rare disease Europe
- Keyword (es)
- Eficacia tratamiento Ensayo clínico Ensayo preclínico Hombre Legislación Medicamento huérfano Placebo Pronóstico Investigación desarrollo Salud pública Enfermedad huérfana Enfermedad rara Europa
- Classification
- Pascal
- 002 Biological and medical sciences / 002B Medical sciences / 002B02 Pharmacology. Drug treatments / 002B02A General pharmacology / 002B02A06 Clinical trial. Drug monitoring
- Discipline
- General pharmacology
- Origin
- Inist-CNRS
- Database
- PASCAL
- INIST identifier
- 27382763
Sauf mention contraire ci-dessus, le contenu de cette notice bibliographique peut être utilisé dans le cadre d’une licence CC BY 4.0 Inist-CNRS / Unless otherwise stated above, the content of this bibliographic record may be used under a CC BY 4.0 licence by Inist-CNRS / A menos que se haya señalado antes, el contenido de este registro bibliográfico puede ser utilizado al amparo de una licencia CC BY 4.0 Inist-CNRS
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DOI
10.1007/s00228-012-1423-2 
https://dx.doi.org/10.1007/s00228-012-1423-2
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