Clinical pharmacology as a cornerstone of orphan drug development.

Nat Rev Drug Discov

Office of Translational Sciences, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.

Published: October 2011

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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Source
http://dx.doi.org/10.1038/nrd3595DOI Listing

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