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. 2011 Oct 31;10(11):795-6.
doi: 10.1038/nrd3595.

Clinical pharmacology as a cornerstone of orphan drug development

Edward D Bashaw  1 , 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, Lawrence J Lesko
Affiliations

Clinical pharmacology as a cornerstone of orphan drug development

Edward D Bashaw et al. Nat Rev Drug Discov. .

Abstract

A 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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References

    1. Pharm Stat. 2009 Jul-Sep;8(3):216-24 - PubMed
    1. Clin Pharmacol Ther. 2007 Feb;81(2):213-21 - PubMed
    1. Nat Rev Drug Discov. 2010 Jul;9(7):519-22 - PubMed
    1. Nat Rev Drug Discov. 2010 Dec;9(12):921-9 - PubMed
    1. Clin Pharmacol Ther. 2011 Feb;89(2):259-67 - PubMed

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