Driving Efficiency: Leveraging Model-Informed Approaches in 505(b)(2) Regulatory Actions.

Sharma, Vishnu Dutt; Bhattaram, Venkatesh Atul; Krudys, Kevin; Li, Zhihua; Marathe, Anshu; Mehrotra, Nitin; Wang, Xiaofeng; Liu, Jiang; Stier, Ethan; Florian, Jeffry; Madabushi, Raj; Zhu, Hao

Sharma, Vishnu Dutt; Bhattaram, Venkatesh Atul; Krudys, Kevin; Li, Zhihua; Marathe, Anshu; Mehrotra, Nitin; Wang, Xiaofeng; Liu, Jiang; Stier, Ethan; Florian, Jeffry; Madabushi, Raj; Zhu, Hao.

Afiliação

Sharma VD; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Bhattaram VA; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Krudys K; Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Li Z; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Marathe A; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Mehrotra N; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Wang X; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Liu J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Stier E; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Florian J; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Madabushi R; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Zhu H; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.