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Pivotal studies of orphan drugs approved for neurological diseases
Annals of Neurology , 09/18/09
Mitsumoto J et al. – The US Food and Drug Administration has approved orphan drugs for neurological diseases without randomized, doubled–blind, placebo–controlled pivotal trials. As orphan drug development grows, demand will likely increase for alternative designs for conducting adequate and well–controlled studies to demonstrate drug efficacy.
Today in Drug Approvals...keeping you current
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American Family Physician, 10/22/09
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Today in Neuro/Psych pharmacology...keeping you current
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Cardiometabolic Risk of Second-Generation Antipsychotic Medications During First-Time Use in Children and Adolescents
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