Vicente Jose, Strauss David G, Upreti Vijay V, Fossler Michael J, Sager Philip T, Noveck Robert
Division of Cardiovascular and Renal Products, Office of Drug Evaluation I, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Division of Applied Regulatory Science, US Food and Drug Administration, Silver Spring, MD, USA.
J Clin Pharmacol. 2019 Jul;59(7):909-914. doi: 10.1002/jcph.1411. Epub 2019 Mar 25.