• Nat Rev Drug Discov · Oct 2011

    Clinical pharmacology as a cornerstone of orphan drug development.

    • Edward D Bashaw, Shiew-Mei Huang, Timothy R Coté, Anne R Pariser, Christine E Garnett, Gilbert Burckart, Lei Zhang, Angela Y Men, Christine D Le, Rosane Charlab, Jogaro V Gobburu, and Lawrence J Lesko.
    • Office of Translational Sciences, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA. Edward.bashaw@fda.hhs.gov
    • Nat Rev Drug Discov. 2011 Oct 31; 10 (11): 795-6.

    AbstractA recent US Food and Drug Administration (FDA) advisory committee meeting highlighted the potential of clinical pharmacology to overcome challenges in orphan drug development.

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