| Authors: |
Strasinger C; Office of Pharmaceutical Quality, Center for Drug Evaluations and Research (CDER), United States Food and Drug Administration (US FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Raney SG; Office of Research and Standards, Office of Generic Drugs, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Tran DC; Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Ghosh P; Office of Research and Standards, Office of Generic Drugs, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Newman B; Office of Research and Standards, Office of Generic Drugs, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Bashaw ED; Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Ghosh T; Office of Pharmaceutical Quality, Center for Drug Evaluations and Research (CDER), United States Food and Drug Administration (US FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Shukla CG; Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. Electronic address: Chinmay.Shukla@fda.hhs.gov. |