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Pivotal Studies of Orphan Drugs Approved for Neurological Diseases

OBJECTIVE: To identify design elements of clinical trials leading to US Food and Drug Administration approval of drugs for neurological diseases with and without orphan indications. METHODS: We used publicly available information to identify approvals for drugs for neurological diseases with an orph...

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Autori principali: Mitsumoto, Jun, Dorsey, E. Ray, Beck, Christopher A., Kieburtz, Karl, Griggs, Robert C.
Natura: Artigo
Lingua:Inglês
Pubblicazione: 2009
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Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC3785304/
https://ncbi.nlm.nih.gov/pubmed/19743448
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/ana.21676
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