The ICH E14 guidance recommends that all new drugs with systemic bioavailability are assessed for the ability to delay cardiac repolarization as measured by the QT/QTc interval on the surface ECG. For most drugs, this evaluation is performed in the Thorough QT/QTc (TQT) study. Could using model-based approaches during routine early studies influence the current […]Read More
Author: Christine Garnett
Dr. Garnett joined Certara in 2012 after serving seven years in the Division of Pharmacometrics at the US Food and Drug Administration, where she held positions of both Associate Director of Operations and Team Leader in the therapeutic areas of oncology, hematology, metabolism, endocrine, and gastroenterology. Her expertise includes exposure-response modeling for regulatory decisions; optimizing dose based on exposure-response and population pharmacokinetic analyses; dose selection and design of pediatric trials; and trial design and evaluation of drug effects on cardiac repolarization. At the FDA, she held leadership roles in the area of cardiac safety where she served as Scientific Lead of CDER’s Interdisciplinary Team for QT Studies and FDA topic leader for the ICH E14 Implementation Working Group. Dr. Garnett has published 28 peer-reviewed articles and has given 22 invited presentations at national and international scientific meetings. She earned a PharmD from the University of Maryland and completed a clinical pharmacology fellowship with a focus in pharmacometrics from the Center for Drug Development Science at Georgetown University.