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Clinical Pharmacology and Orphan Drugs: An Informational Inventory 2006–2010
Author(s) -
Bashaw E D,
Fang L
Publication year - 2012
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2012.23
Subject(s) - clinical pharmacology , orphan drug , food and drug administration , pharmacology , medicine , drug , advisory committee , bioinformatics , biology , political science , public administration
Clinical pharmacology can have an important impact on the development of orphan drugs, i.e., therapeutic agents for rare diseases. This topic was explored at a US Food and Drug Administration (FDA) Advisory Committee meeting in March 2011. 1 At that meeting, preliminary data were presented regarding the breakdown of the clinical pharmacology content in the approvals for orphan drugs in 2006–2010. These data, along with follow‐up observations, are presented here, focusing on the in vivo study content and the relevant populations. Clinical Pharmacology & Therapeutics (2012); 91 5, 932–936. doi: 10.1038/clpt.2012.23