X
Search Filters
Format Format
Subjects Subjects
Subjects Subjects
X
Sort by Item Count (A-Z)
Filter by Count
ich e14 (53) 53
humans (44) 44
index medicus (43) 43
pharmacology & pharmacy (43) 43
long qt syndrome - chemically induced (25) 25
electrocardiography (24) 24
moxifloxacin (20) 20
adult (18) 18
female (18) 18
male (18) 18
thorough qt (18) 18
thorough qt study (17) 17
dose-response relationship, drug (16) 16
drugs (16) 16
middle aged (16) 16
qt interval (16) 16
qt prolongation (16) 16
electrocardiogram (14) 14
electrocardiography - drug effects (14) 14
thorough qt/qtc study (14) 14
cross-over studies (13) 13
qt/qtc (13) 13
young adult (13) 13
heart rate - drug effects (12) 12
ich s7b (12) 12
safety (12) 12
double-blind method (11) 11
drug development (11) 11
interval prolongation (11) 11
adolescent (10) 10
animals (10) 10
arrhythmia (10) 10
ich (10) 10
prolongation (10) 10
qtc (9) 9
ich e14 guideline (8) 8
pharmacokinetics (8) 8
pharmacology (8) 8
repolarization (8) 8
torsade de pointes (8) 8
analysis (7) 7
arrhythmias, cardiac - chemically induced (7) 7
cardiac arrhythmia (7) 7
cardiac repolarization (7) 7
drug-related side effects and adverse reactions (7) 7
drugs, investigational - adverse effects (7) 7
fluoroquinolones (7) 7
food and drug administration (7) 7
pharmacology/toxicology (7) 7
qt interval prolongation (7) 7
clinical trials as topic (6) 6
dosage and administration (6) 6
drug therapy (6) 6
heart rate (6) 6
interval (6) 6
long qt syndrome - diagnosis (6) 6
long qt syndrome - physiopathology (6) 6
qtc study (6) 6
risk (6) 6
risk factors (6) 6
safety pharmacology (6) 6
statistics & probability (6) 6
time factors (6) 6
torsades de pointes (6) 6
torsades de pointes - chemically induced (6) 6
torsades-de-pointes (6) 6
aza compounds - adverse effects (5) 5
clinical trials (5) 5
de-pointes (5) 5
design (5) 5
exposure-response analysis (5) 5
guidelines as topic (5) 5
herg (5) 5
international conference on harmonization (5) 5
liability (5) 5
long qt syndrome (5) 5
oncology (5) 5
proarrhythmia (5) 5
proarrhythmic risk (5) 5
qt/qtc interval (5) 5
quinolines - adverse effects (5) 5
risk assessment (5) 5
risk assessment - methods (5) 5
terfenadine (5) 5
torsade-de-pointes (5) 5
ventricular repolarization (5) 5
biomedicine (4) 4
cardiac & cardiovascular systems (4) 4
cardiovascular safety (4) 4
care and treatment (4) 4
cisapride (4) 4
clinical-trials (4) 4
drug approval (4) 4
drug design (4) 4
drug evaluation, preclinical (4) 4
electrophysiology (4) 4
evaluation (4) 4
heart-rate (4) 4
herg channel (4) 4
international cooperation (4) 4
more...
Language Language
Publication Date Publication Date
Click on a bar to filter by decade
Slide to change publication date range


Journal of Pharmacological and Toxicological Methods, ISSN 1056-8719, 09/2010, Volume 62, Issue 2, pp. 143 - 147
Journal Article
Journal of Pharmacological Sciences, ISSN 1347-8613, 04/2018, Volume 136, Issue 4, pp. 234 - 241
Effects of moxifloxacin on QTc as well as proarrhythmic surrogate markers including J-Tpeakc, Tpeak-Tend and short-term variability (STV) of repolarization... 
Thorough QT study | Moxifloxacin | J-Tpeak | Exposure-response modeling | ICH E14 | J-T | Electrocardiography | Usage | Dosage and administration | Electrocardiogram
Journal Article
心電図, ISSN 0285-1660, 2007, Volume 27, Issue 1, pp. 83 - 92
近年, 薬剤誘発性QT延長症候群による突然死が社会的問題となっている.すべての新薬の安全性を確保するために, 開発段階で心電図QT間隔を計測する国際的なガイドライン (ICH-E14) が提案されている.われわれはICH-E14に基づいた新しいQT計測システムを開発した.このシステムは,... 
QT間隔 | 薬剤誘発性 | QT延長 | 心毒性治験
Journal Article
The Journal of Clinical Pharmacology, ISSN 0091-2700, 01/2020, Volume 60, Issue 1, pp. 125 - 139
The JTpeak interval has been proposed as a new biomarker to demonstrate mixed ion channel effects, potentially leading to reduced late‐stage electrocardiogram... 
QTc | torsades de pointes | JTpeak | Cardiovascular | Clinical Pharmacology | ICH E14 | Proarrhythmic | Drugs | EKG | Statistical analysis | Intelligence | Waveforms | Moxifloxacin | Quinine | Heart rate | Sodium | Dependent variables | Electrocardiography | Biomarkers | Ion channels
Journal Article
The Journal of Clinical Pharmacology, ISSN 0091-2700, 08/2011, Volume 51, Issue 8, pp. 1152 - 1162
To increase our understanding of important subject characteristics and design variables affecting the performance of oral moxifloxacin in thorough QT studies,... 
Population pharmacokinetics | QT prolongation | exposure—response modeling | thorough QT studies | ICH E14 | moxifloxacin | exposure-response modeling | WOMEN | INTERVAL PROLONGATION | TRAFFICKING | PHARMACOLOGY & PHARMACY | QT/QTC | QUINIDINE | Fluoroquinolones | Aza Compounds - pharmacokinetics | Quinolines - blood | Drugs, Investigational - adverse effects | Anti-Infective Agents - blood | United States | Humans | Middle Aged | Drugs, Investigational - pharmacokinetics | Aza Compounds - adverse effects | Male | Metabolic Clearance Rate | Quinolines - administration & dosage | Drugs, Investigational - analysis | Intestinal Absorption | Delayed-Action Preparations - administration & dosage | Quinolines - pharmacokinetics | Young Adult | Delayed-Action Preparations - pharmacokinetics | Adult | Aza Compounds - blood | Female | United States Food and Drug Administration | Aza Compounds - administration & dosage | Anti-Infective Agents - adverse effects | Administration, Oral | Electrocardiography - drug effects | Clinical Trials as Topic | Animals | Anti-Infective Agents - administration & dosage | Delayed-Action Preparations - adverse effects | Models, Biological | Anti-Infective Agents - pharmacokinetics | Adolescent | Drugs, Investigational - administration & dosage | Aged | Quinolines - adverse effects | Physiological aspects | Moxifloxacin | Research | Demographic aspects | Pharmacokinetics
Journal Article
British Journal of Clinical Pharmacology, ISSN 0306-5251, 01/2015, Volume 79, Issue 1, pp. 117 - 131
Journal Article
Annals of Noninvasive Electrocardiology, ISSN 1082-720X, 07/2015, Volume 20, Issue 4, pp. 368 - 377
Journal Article
Expert Opinion on Drug Safety, ISSN 1474-0338, 07/2005, Volume 4, Issue 4, pp. 795 - 799
This meeting, jointly sponsored by the FDA, Drug Information Association and Heart Rhythm Society, examined crucial issues on nonclinical and clinical... 
thorough QT/QTc study | repolarisation risk | nonclinical evaluation | E14 | International Conference on Harmonisation (ICH) gu | Food and Drug Administration (FDA) | S7B
Journal Article
Journal Article
Expert Review of Clinical Pharmacology, ISSN 1751-2433, 12/2016, Volume 9, Issue 12, pp. 1611 - 1618
Introduction: hERG assays and thorough ECG trials have been mandated since 2005 to evaluate the QT interval and potential proarrhythmic risk of new chemical... 
QT interval | hERG | comprehensive in vitro proarrhythmia assay | cardiovascular safety | Torsades de pointes | ICH E14 | exposure response modelling | Thorough QT | ICH S7B | proarrhythmia | LONG-QT | DISPERSION | HUMANS | LIABILITY | QT INTERVAL PROLONGATION | ISSUES | NONCARDIAC DRUGS | TORSADE-DE-POINTES | PHARMACOLOGY & PHARMACY
Journal Article