Keywords: PAH; Thorough QT study; QT prolongation; Moxifloxacin; ICH E14
مقالات ISI (ترجمه نشده)
مقالات زیر هنوز به فارسی ترجمه نشده اند.
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در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
Effects of moxifloxacin on the proarrhythmic surrogate markers in healthy Filipino subjects: Exposure-response modeling using ECG data of thorough QT/QTc study
Keywords: ICH E14; Moxifloxacin; Thorough QT study; Exposure-response modeling; J-Tpeak;
The prospective IQ-CSRC trial: A prototype early clinical proarrhythmia assessment investigation for replacing the ICH E14 thorough QTc (TQT) study
Keywords: AP; cardiac action potential; CiPA; comprehensive in vitro proarrhythmia assay; CSRC; Cardiac Safety Research Consortium; Cmax; maximal plasma concentration; CTWG; clinical translational working group; DRest; rate-normalized Tpeak â Tend = Tpe inter
Differentiating the Effect of an Opioid Agonist on Cardiac Repolarization From µ-Receptor-mediated, Indirect Effects on the QT Interval: A Randomized, 3-way Crossover Study in Healthy Subjects
Keywords: µ-receptor blockade; buprenorphine; naltrexone; opioids; QT prolongation; thorough QT study;
Comprehensive in vitro Proarrhythmia Assay (CiPA): Pending issues for successful validation and implementation
Keywords: Comprehensive in vitro Proarrhythmia Assay (CiPA); Field potential data sampling and analysis; Induced pluripotent cell cardiomyocytes (hiPSC-CMs); Multi electrode array (MEA); Patch clamp technologies; Pending issues and solutions; Validation; Voltage se
A thorough QT study with dalbavancin: A novel lipoglycopeptide antibiotic for the treatment of acute bacterial skin and skin-structure infections
Keywords: QT; QTc prolongation; Thorough QT study; Dalbavancin; Anti-infective drug; Acute bacterial skin and skin-structure infection;
Timing of pre-dose baseline electrocardiograms in clinical trials: Increased sampling over a prolonged baseline period worsens variance of QTc
Keywords: Electrocardiogram; Thorough QT study; Clinical trial; Standard deviation
A public-private consortium advances cardiac safety evaluation: Achievements of the HESI Cardiac Safety Technical Committee
Keywords: ADRs; adverse drug reactions; CDER; Center for Drug Evaluation and Research; cTn; cardiac troponin; CV; cardiovascular; EMA; European Medicines Agency; EWG; Expert Working Group; ECG; electrocardiogram; HESI; Health and Environmental Sciences Institute; h
Comparative TQT analysis with three fully-automated platforms: Comparison to core laboratory semi-automated results
Keywords: Fully-automated QT analysis; QT measurement; Thorough QT study; ECG core laboratory;
Assessment of the sensitivity of detecting drug-induced QTc changes using subject-specific rate correction
Keywords: Thorough QT study; Corrected QT; Drug-induced QT prolongation; Subject-specific correction
Assessing electrocardiographic data quality and possible replacement of pharmacologic positive control in thorough QT/QTc studies by investigations of drug-free QTc stability
Keywords: ECG measurement; Measurement reproducibility; Measurement stability; Positive control; QTc interval; Thorough QT study; CI; confidence interval; QTc; corrected QT interval; SD; standard deviation; TQTS; thorough QT/QTc study;
A Placebo- and Active-Controlled Assessment of 6- and 50-mg Oral Doxepin on Cardiac Repolarization in Healthy Volunteers: A Thorough QT Evaluation
Keywords: doxepin; insomnia; moxifloxacin; nordoxepin; thorough QT study
Differences between QT and RR intervals in digital and digitized paper electrocardiograms: contribution of the printer, scanner, and digitization process
Keywords: Central laboratory; QTc interval; Thorough QT study; New drug development; Extensible markup language (XML); Document scanner; Cardiac repolarization; Clinical trials
If a drug deemed 'safe' in nonclinical tests subsequently prolongs QT in phase 1 studies, how can its sponsor convince regulators to allow development to proceed?
Keywords: CHMP; Committee for Medicinal Products for Human Use; COX; Cycloxygenase; ECG; Electrocardiogram; EU; European Union; FDA; Food and Drug Administration of the United States; hERG; Human ether-a-go-go related gene; ICH; International Conference on Harmoniz