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Christine Garnett
Christine Garnett
Verified email at fda.hhs.gov
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Year
Concentration‐QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review
CE Garnett, N Beasley, VA Bhattaram, PR Jadhav, R Madabushi, ...
The Journal of Clinical Pharmacology 48 (1), 13-18, 2008
2442008
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008
JY Lee, CE Garnett, JVS Gobburu, VA Bhattaram, S Brar, JC Earp, ...
Clinical pharmacokinetics 50, 627-635, 2011
1742011
US Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis
A Deisseroth, E Kaminskas, J Grillo, W Chen, H Saber, HL Lu, ...
Clinical Cancer Research 18 (12), 3212-3217, 2012
1692012
Tasigna for chronic and accelerated phase Philadelphia chromosome–positive chronic myelogenous leukemia resistant to or intolerant of imatinib
M Hazarika, X Jiang, Q Liu, SL Lee, R Ramchandani, C Garnett, MS Orr, ...
Clinical Cancer Research 14 (17), 5325-5331, 2008
1692008
Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: US Food and Drug …
K Thornton, G Kim, VE Maher, S Chattopadhyay, S Tang, YJ Moon, ...
Clinical Cancer Research 18 (14), 3722-3730, 2012
1682012
Scientific white paper on concentration-QTc modeling
C Garnett, PL Bonate, Q Dang, G Ferber, D Huang, J Liu, D Mehrotra, ...
Journal of Pharmacokinetics and Pharmacodynamics 45, 383-397, 2018
1662018
Results from the IQ‐CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase
B Darpo, C Benson, C Dota, G Ferber, C Garnett, CL Green, V Jarugula, ...
Clinical Pharmacology & Therapeutics 97 (4), 326-335, 2015
1662015
Dealing with global safety issues: was the response to QT-liability of non-cardiac drugs well coordinated?
N Stockbridge, J Morganroth, RR Shah, C Garnett
Drug safety 36, 167-182, 2013
1662013
Population pharmacokinetic and concentration—QTc models for moxifloxacin: pooled analysis of 20 thorough QT studies
JA Florian, CW Tornĝe, R Brundage, A Parekh, CE Garnett
The Journal of Clinical Pharmacology 51 (8), 1152-1162, 2011
1652011
Impact of pharmacometric reviews on new drug approval and labeling decisions—a survey of 31 new drug applications submitted between 2005 and 2006
VA Bhattaram, C Bonapace, DM Chilukuri, JZ Duan, C Garnett, ...
Clinical Pharmacology & Therapeutics 81 (2), 213-221, 2007
1472007
Mechanistic model‐informed proarrhythmic risk assessment of drugs: review of the “CiPA” initiative and design of a prospective clinical validation study
J Vicente, R Zusterzeel, L Johannesen, J Mason, P Sager, V Patel, ...
Clinical Pharmacology & Therapeutics 103 (1), 54-66, 2018
1182018
Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects
CE Garnett, H Zhu, M Malik, AA Fossa, J Zhang, F Badilini, J Li, B Darpö, ...
American heart journal 163 (6), 912-930, 2012
1182012
The IQ‐CSRC prospective clinical phase 1 study:“Can early QT assessment using exposure response analysis replace the thorough QT study?”
B Darpo, N Sarapa, C Garnett, C Benson, C Dota, G Ferber, V Jarugula, ...
Annals of Noninvasive Electrocardiology 19 (1), 70-81, 2014
1102014
The combination of exposure‐response and case‐control analyses in regulatory decision making
J Yang, H Zhao, C Garnett, A Rahman, JV Gobburu, W Pierce, ...
The Journal of Clinical Pharmacology 53 (2), 160-166, 2013
1082013
Assessing proarrhythmic potential of drugs when optimal studies are infeasible
EP Rock, J Finkle, HJ Fingert, BP Booth, CE Garnett, S Grant, RL Justice, ...
American heart journal 157 (5), 827-836. e1, 2009
972009
Improving the assessment of heart toxicity for all new drugs through translational regulatory science
L Johannesen, J Vicente, RA Gray, L Galeotti, Z Loring, CE Garnett, ...
Clinical Pharmacology & Therapeutics 95 (5), 501-508, 2014
932014
Creation of a knowledge management system for QT analyses
CW Tornĝe, CE Garnett, Y Wang, J Florian, M Li, JV Gobburu
The Journal of Clinical Pharmacology 51 (7), 1035-1042, 2011
802011
Cardiac Safety Research Consortium: can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research …
B Darpo, C Garnett, CT Benson, J Keirns, D Leishman, M Malik, ...
American heart journal 168 (3), 262-272, 2014
712014
Assessment of Multi‐Ion Channel Block in a Phase I Randomized Study Design: Results of the Ci PA Phase I ECG Biomarker Validation Study
J Vicente, R Zusterzeel, L Johannesen, R Ochoa‐Jimenez, JW Mason, ...
Clinical Pharmacology & Therapeutics 105 (4), 943-953, 2019
692019
Are women more susceptible than men to drug‐induced QT prolongation? Concentration–QTc modelling in a phase 1 study with oral rac‐sotalol
B Darpo, DR Karnad, F Badilini, J Florian, CE Garnett, S Kothari, ...
British Journal of Clinical Pharmacology 77 (3), 522-531, 2014
592014
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