Margaret Mizah, PharmD
Articles
March 14th 2014
Assessing the Chiral Switch: Approval and Use of Single-Enantiomer Drugs, 2001 to 2011
Walid F. Gellad, MD, MPH Phillip Choi, BS Margaret Mizah, PharmD Chester B. Good, MD, MPH Aaron S. Kesselheim, MD, JD, MPH
From 2001 to 2011, the US Food and Drug Administration approved 9 single-enantiomer drugs with racemic precursors. None showed pre-approval evidence of improved efficacy over the racemic precursor.
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