-
Clin. Pharmacol. Ther. · May 2012
Clinical pharmacology and orphan drugs: an informational inventory 2006-2010.
- E D Bashaw and L Fang.
- Division of Clinical Pharmacology-3, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland, USA.
- Clin. Pharmacol. Ther. 2012 May 1; 91 (5): 932-6.
AbstractClinical 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.
Notes
Knowledge, pearl, summary or comment to share?You can also include formatting, links, images and footnotes in your notes
- Simple formatting can be added to notes, such as
*italics*,_underline_or**bold**. - Superscript can be denoted by
<sup>text</sup>and subscript<sub>text</sub>. - Numbered or bulleted lists can be created using either numbered lines
1. 2. 3., hyphens-or asterisks*. - Links can be included with:
[my link to pubmed](http://pubmed.com) - Images can be included with:
 - For footnotes use
[^1](This is a footnote.)inline. - Or use an inline reference
[^1]to refer to a longer footnote elseweher in the document[^1]: This is a long footnote..