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Clinical pharmacology as a cornerstone of orphan drug development |
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| 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 |
| Affiliation: | Office of Translational Sciences, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA. Edward.bashaw@fda.hhs.gov |
| 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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| 本文献已被 PubMed 等数据库收录！ | |