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Clinical pharmacology as a cornerstone of orphan drug development
Nature Reviews Drug Discovery, 2011Lawrence Lesko
exaly
2019
Summary. The drug approval process consists of two stages: clinical trials (CT) and new drug application (NDA) approval. Orphan drugs are medicines or vaccines intended to treat, prevent or diagnose a rare disease. New programs in orphan drug development may offer valuable solutions to bring orphan treatments to the market more quickly in despite of ...
Noemi Giannetta +5 more
openaire +1 more source
Summary. The drug approval process consists of two stages: clinical trials (CT) and new drug application (NDA) approval. Orphan drugs are medicines or vaccines intended to treat, prevent or diagnose a rare disease. New programs in orphan drug development may offer valuable solutions to bring orphan treatments to the market more quickly in despite of ...
Noemi Giannetta +5 more
openaire +1 more source
Worldwide collaboration for orphan drug designation
Nature Reviews Drug Discovery, 2016Bruno Sepodes
exaly
European regulation on orphan medicinal products: 10 years of experience and future perspectives
Nature Reviews Drug Discovery, 2011Bruno Sepodes +2 more
exaly
Issues Aired Related to Orphan Drug Products at Washington Hearing
American Journal of Health-System Pharmacy, 1983openaire +1 more source
Does orphan drug legislation really answer the needs of patients?
Lancet, The, 2008Josep Torrent-Farnell
exaly
The Committee for Orphan Medicinal Products of the EMEA has granted orphan drug status to maribavir
Inpharma Weekly, 2007openaire +1 more source