Detalhe da pesquisa
1.
Enrichment Benefits of Risk Algorithms for Pulmonary Arterial Hypertension Clinical Trials.
Am J Respir Crit Care Med
; 203(6): 726-736, 2021 03 15.
Artigo
Inglês
| MEDLINE | ID: mdl-32937078
2.
Detection and impact of hysteresis when evaluating a drug's QTc effect using concentration-QTc analysis.
J Pharmacokinet Pharmacodyn
; 48(2): 187-202, 2021 04.
Artigo
Inglês
| MEDLINE | ID: mdl-33118135
3.
Importance of QT/RR hysteresis correction in studies of drug-induced QTc interval changes.
J Pharmacokinet Pharmacodyn
; 45(3): 491-503, 2018 06.
Artigo
Inglês
| MEDLINE | ID: mdl-29651591
4.
Correction to: Scientific white paper on concentration-QTc modeling.
J Pharmacokinet Pharmacodyn
; 45(3): 399, 2018 06.
Artigo
Inglês
| MEDLINE | ID: mdl-29330761
5.
Scientific white paper on concentration-QTc modeling.
J Pharmacokinet Pharmacodyn
; 45(3): 383-397, 2018 06.
Artigo
Inglês
| MEDLINE | ID: mdl-29209907
6.
Applying Decision Analysis to Inform the US Food and Drug Administration's Benefit-Risk Assessment of Ticagrelor for Primary Prevention of Myocardial Infarction or Stroke Based on THEMIS.
Circulation
; 144(8): 655-658, 2021 08 24.
Artigo
Inglês
| MEDLINE | ID: mdl-34424771
7.
Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response.
J Pediatr Gastroenterol Nutr
; 65(3): 272-277, 2017 09.
Artigo
Inglês
| MEDLINE | ID: mdl-27875488
8.
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 proposal for a path forward.
Am Heart J
; 168(3): 262-72, 2014 Sep.
Artigo
Inglês
| MEDLINE | ID: mdl-25173536
9.
Are women more susceptible than men to drug-induced QT prolongation? Concentration-QTc modelling in a phase 1 study with oral rac-sotalol.
Br J Clin Pharmacol
; 77(3): 522-31, 2014 Mar.
Artigo
Inglês
| MEDLINE | ID: mdl-23819796
10.
The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".
Ann Noninvasive Electrocardiol
; 19(1): 70-81, 2014 Jan.
Artigo
Inglês
| MEDLINE | ID: mdl-24372708
11.
Early QT assessment--how can our confidence in the data be improved?
Br J Clin Pharmacol
; 76(5): 642-8, 2013 Nov.
Artigo
Inglês
| MEDLINE | ID: mdl-23278510
12.
ICH S7B In Vitro Assays Do Not Address Mechanisms of QTC Prolongation for Peptides and Proteins - Data in Support of Not Needing Dedicated QTC Studies.
Clin Pharmacol Ther
; 114(6): 1332-1341, 2023 12.
Artigo
Inglês
| MEDLINE | ID: mdl-37702218
13.
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation.
Ther Innov Regul Sci
; 57(1): 109-120, 2023 01.
Artigo
Inglês
| MEDLINE | ID: mdl-36057747
14.
Methodologies to characterize the QT/corrected QT interval in the presence of drug-induced heart rate changes or other autonomic effects.
Am Heart J
; 163(6): 912-30, 2012 Jun.
Artigo
Inglês
| MEDLINE | ID: mdl-22709743
15.
Practice and challenges of thorough QT studies.
J Electrocardiol
; 45(6): 582-7, 2012.
Artigo
Inglês
| MEDLINE | ID: mdl-22999322
16.
The Challenges of Predicting Drug-Induced QTc Prolongation in Humans.
Toxicol Sci
; 187(1): 3-24, 2022 04 26.
Artigo
Inglês
| MEDLINE | ID: mdl-35148401
17.
Highly automated QT measurement techniques in 7 thorough QT studies implemented under ICH E14 guidelines.
Ann Noninvasive Electrocardiol
; 16(1): 13-24, 2011 Jan.
Artigo
Inglês
| MEDLINE | ID: mdl-21251129
18.
Translational Models and Tools to Reduce Clinical Trials and Improve Regulatory Decision Making for QTc and Proarrhythmia Risk (ICH E14/S7B Updates).
Clin Pharmacol Ther
; 109(2): 319-333, 2021 02.
Artigo
Inglês
| MEDLINE | ID: mdl-33332579
19.
Understanding Circadian Mechanisms of Sudden Cardiac Death: A Report From the National Heart, Lung, and Blood Institute Workshop, Part 1: Basic and Translational Aspects.
Circ Arrhythm Electrophysiol
; 14(11): e010181, 2021 11.
Artigo
Inglês
| MEDLINE | ID: mdl-34719240
20.
Understanding Circadian Mechanisms of Sudden Cardiac Death: A Report From the National Heart, Lung, and Blood Institute Workshop, Part 2: Population and Clinical Considerations.
Circ Arrhythm Electrophysiol
; 14(11): e010190, 2021 11.
Artigo
Inglês
| MEDLINE | ID: mdl-34719257