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- Title
Clinical pharmacology as a cornerstone of orphan drug development.
- Authors
Bashaw, Edward D.; Huang, Shiew-Mei; Coté, Timothy R.; Pariser, Anne R.; Garnett, Christine E.; Burckart, Gilbert; Zhang, Lei; Men, Angela Y.; Le, Christine D.; Charlab, Rosane; Gobburu, Jogaro V.; Lesko, Lawrence J.; Coté, Timothy R
- 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.
- Subjects
ORPHAN drugs; DRUG development; PHARMACOLOGY; MEDICAL prescriptions; UNITED States. Food &; Drug Administration; MARKETING
- Publication
Nature Reviews Drug Discovery, 2011, Vol 10, Issue 11, p795
- ISSN
1474-1776
- Publication type
journal article
- DOI
10.1038/nrd3595