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 | 245 | 2008 |
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 | 176 | 2011 |
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 | 172 | 2012 |
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 | 170 | 2018 |
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 | 169 | 2015 |
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 | 169 | 2012 |
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 | 169 | 2008 |
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 | 167 | 2013 |
Population pharmacokinetic and concentration—QTc models for moxifloxacin: pooled analysis of 20 thorough QT studies JA Florian, CW Tornøe, R Brundage, A Parekh, CE Garnett The Journal of Clinical Pharmacology 51 (8), 1152-1162, 2011 | 166 | 2011 |
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 | 149 | 2007 |
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 | 119 | 2012 |
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 | 118 | 2018 |
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 | 110 | 2014 |
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 | 108 | 2013 |
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 | 97 | 2009 |
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 | 94 | 2014 |
Creation of a knowledge management system for QT analyses CW Tornøe, CE Garnett, Y Wang, J Florian, M Li, JV Gobburu The Journal of Clinical Pharmacology 51 (7), 1035-1042, 2011 | 81 | 2011 |
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 | 72 | 2014 |
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 | 70 | 2019 |
Translational models and tools to reduce clinical trials and improve regulatory decision making for QTc and proarrhythmia risk (ICH E14/S7B updates) DG Strauss, WW Wu, Z Li, J Koerner, C Garnett Clinical Pharmacology & Therapeutics 109 (2), 319-333, 2021 | 60 | 2021 |