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Discovery and Model‐Informed Drug Development of a Controlled‐Release Formulation of Nonracemic Amisulpride that Reduces Plasma Exposure but Achieves Pharmacodynamic Bioequivalence in the Brain.
- Published in:
- Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 2, p. 460, doi. 10.1002/cpt.3311
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- Publication type:
- Article
Concentration‐QTcF Modeling of Icenticaftor from a Randomized, Placebo‐ and Positive‐Controlled Thorough QT Study in Healthy Participants.
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- Clinical Pharmacology in Drug Development, 2024, v. 13, n. 5, p. 572, doi. 10.1002/cpdd.1374
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- Publication type:
- Article
Cardiovascular Evaluation of Etrasimod, a Selective Sphingosine 1‐phosphate Receptor Modulator, in Healthy Adults: Results of a Randomized, Thorough QT/QTc Study.
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- Clinical Pharmacology in Drug Development, 2024, v. 13, n. 4, p. 326, doi. 10.1002/cpdd.1388
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- Article
The New S7B/E14 Q&A Document Provides Additional Opportunities to Replace the Thorough QT Study.
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- Journal of Clinical Pharmacology, 2023, v. 63, n. 11, p. 1256, doi. 10.1002/jcph.2309
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- Article
Concentration–QTc Relationship from a Single Ascending Dose Study of ANAVEX3‐71, a Novel Sigma‐1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for the Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease
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- Clinical Pharmacology in Drug Development, 2023, v. 12, n. 9, p. 888, doi. 10.1002/cpdd.1303
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- Article
A randomized, single‐dose, crossover study of the effects of ulotaront on electrocardiogram intervals in subjects with schizophrenia.
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- CTS: Clinical & Translational Science, 2023, v. 16, n. 6, p. 1063, doi. 10.1111/cts.13512
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- Article
Pridopidine Does Not Significantly Prolong the QTc Interval at the Clinically Relevant Therapeutic Dose.
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- Neurology & Therapy, 2023, v. 12, n. 2, p. 597, doi. 10.1007/s40120-023-00449-w
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- Article
Evaluation of Deutetrabenazine's Potential to Delay Cardiac Repolarization Using Concentration‐QTc Analysis.
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- Clinical Pharmacology in Drug Development, 2023, v. 12, n. 1, p. 94, doi. 10.1002/cpdd.1161
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- Article
ECG Evaluation as Part of the Clinical Pharmacology Strategy in the Development of New Drugs: A Review of Current Practices and Opportunities Based on Five Case Studies.
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- Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1480, doi. 10.1002/jcph.2095
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- Article
A Phase 1 Thorough QT/QTc Study of Therapeutic and Supratherapeutic Doses of Belumosudil in Healthy Subjects.
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- Clinical Pharmacology in Drug Development, 2022, v. 11, n. 10, p. 1221, doi. 10.1002/cpdd.1142
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- Article
A thorough QTc study to evaluate the effects of oral rilzabrutinib administered alone and with ritonavir in healthy subjects.
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- CTS: Clinical & Translational Science, 2022, v. 15, n. 6, p. 1507, doi. 10.1111/cts.13271
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- Article
A Phase 1 Clinical Study Evaluating the Effects of Cenobamate on the QT Interval.
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- Clinical Pharmacology in Drug Development, 2022, v. 11, n. 4, p. 523, doi. 10.1002/cpdd.1077
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- Article
Omecamtiv mecarbil does not prolong QTc intervals at therapeutic concentrations.
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- British Journal of Clinical Pharmacology, 2022, v. 88, n. 1, p. 187, doi. 10.1111/bcp.14939
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- Article
Electrophysiological and ECG Effects of Perhexiline, a Mixed Cardiac Ion Channel Inhibitor, Evaluated in Nonclinical Assays and in Healthy Subjects.
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- Journal of Clinical Pharmacology, 2021, v. 61, n. 12, p. 1606, doi. 10.1002/jcph.1934
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- Article
Comparison of electrocardiograms (ECG) waveforms and centralized ECG measurements between a simple 6-lead mobile ECG device and a standard 12-lead ECG.
- Published in:
- Annals of Noninvasive Electrocardiology, 2021, v. 26, n. 6, p. 1, doi. 10.1111/anec.12872
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- Article
The New S7B/E14 Question and Answer Draft Guidance for Industry: Contents and Commentary.
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- Journal of Clinical Pharmacology, 2021, v. 61, n. 10, p. 1261, doi. 10.1002/jcph.1880
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- Article
Safety, Pharmacokinetics, and Pharmacodynamics of Trazpiroben (TAK‐906), a Novel Selective D<sub>2</sub>/D<sub>3</sub> Receptor Antagonist: A Phase 1 Randomized, Placebo‐Controlled Single‐ and Multiple‐Dose Escalation Study in Healthy Participants
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- Clinical Pharmacology in Drug Development, 2021, v. 10, n. 8, p. 927, doi. 10.1002/cpdd.906
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- Article
Diurnal QT analysis in patients with sotalol after cardioversion of atrial fibrillation.
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- 2021
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- Publication type:
- journal article
Evaluation of the Potential for QTc Prolongation With Repeated Oral Doses of Fedratinib in Patients With Advanced Solid Tumors.
- Published in:
- Clinical Pharmacology in Drug Development, 2021, v. 10, n. 4, p. 366, doi. 10.1002/cpdd.850
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- Publication type:
- Article
Detection and impact of hysteresis when evaluating a drug's QTc effect using concentration-QTc analysis.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2021, v. 48, n. 2, p. 187, doi. 10.1007/s10928-020-09725-w
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- Article
The effect of the glucosylceramide synthase inhibitor lucerastat on cardiac repolarization: results from a thorough QT study in healthy subjects.
- Published in:
- 2020
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- Publication type:
- journal article
The effect of the glucosylceramide synthase inhibitor lucerastat on cardiac repolarization: results from a thorough QT study in healthy subjects.
- Published in:
- Orphanet Journal of Rare Diseases, 2020, v. 15, n. 1, p. 1, doi. 10.1186/s13023-020-01582-7
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- Publication type:
- Article
No QTc Prolongation With Zanubrutinib: Results of Concentration‐QTc Analysis From a Thorough QT Study in Healthy Subjects.
- Published in:
- CTS: Clinical & Translational Science, 2020, v. 13, n. 5, p. 923, doi. 10.1111/cts.12779
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- Article
Potential strategy for assessing QT/QTc interval for drugs that produce rapid changes in heart rate: Electrocardiographic assessment of the effects of intravenous remimazolam on cardiac repolarization.
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- British Journal of Clinical Pharmacology, 2020, v. 86, n. 8, p. 1600, doi. 10.1111/bcp.14270
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- Article
Evaluation of Clinical Cardiac Safety of Itacitinib, a JAK1 Inhibitor, in Healthy Participants.
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- Clinical Pharmacology in Drug Development, 2020, v. 9, n. 6, p. 677, doi. 10.1002/cpdd.758
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- Publication type:
- Article
Revefenacin, a Long‐Acting Muscarinic Antagonist, Does Not Prolong QT Interval in Healthy Subjects: Results of a Placebo‐ and Positive‐Controlled Thorough QT Study.
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- Clinical Pharmacology in Drug Development, 2020, v. 9, n. 1, p. 130, doi. 10.1002/cpdd.732
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- Article
Evaluation of the Effect of 5 QT‐Positive Drugs on the JTpeak Interval — An Analysis of ECGs From the IQ‐CSRC Study.
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- Journal of Clinical Pharmacology, 2020, v. 60, n. 1, p. 125, doi. 10.1002/jcph.1502
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- Article
Cardiac risk assessment based on early Phase I data and PK-QTc analysis is concordant with the outcome of thorough QTc trials: an assessment based on eleven drug candidates.
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- Journal of Pharmacokinetics & Pharmacodynamics, 2019, v. 46, n. 6, p. 617, doi. 10.1007/s10928-019-09662-3
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- Publication type:
- Article
684. Cardiac Safety in Adults with Community-Acquired Bacterial Pneumonia (CABP) Treated with Lefamulin (LEF) or Moxifloxacin (MOX): Analysis of Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 Study Results.
- Published in:
- Open Forum Infectious Diseases, 2019, v. 6, p. S311, doi. 10.1093/ofid/ofz360.752
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- Article
Evaluating Potential QT Effects of JNJ‐54861911, a BACE Inhibitor in Single‐ and Multiple‐Ascending Dose Studies, and a Thorough QT Trial With Additional Retrospective Confirmation, Using Concentration‐QTc Analysis.
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- Journal of Clinical Pharmacology, 2018, v. 58, n. 7, p. 952, doi. 10.1002/jcph.1087
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- Article
Study Design Parameters Affecting Exposure Response Analysis of QT Data: Results From Simulation Studies.
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- Journal of Clinical Pharmacology, 2018, v. 58, n. 5, p. 674, doi. 10.1002/jcph.1065
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- Publication type:
- Article
Thorough QT/QTc Evaluation of the Cardiac Safety of Secnidazole at Therapeutic and Supratherapeutic Doses in Healthy Individuals.
- Published in:
- Journal of Clinical Pharmacology, 2018, v. 58, n. 3, p. 286, doi. 10.1002/jcph.1014
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- Article
Effects of intranasal kinetic oscillation stimulation on heart rate variability.
- Published in:
- 2018
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- Publication type:
- journal article
ELENBECESTAT, A NOVEL ORAL BACE INHIBITOR, HAS NO CLINICALLY MEANINGFUL EFFECT ON QTC INTERVAL UP TO A SUPRATHERAPEUTIC DOSE OF 200 MG.
- Published in:
- Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 2017, v. 13, p. P250, doi. 10.1016/j.jalz.2017.06.110
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- Article
Solithromycin, a novel macrolide, does not prolong cardiac repolarization: a randomized, three-way crossover study in healthy subjects.
- Published in:
- 2017
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- Publication type:
- journal article
Comparing QT interval variability of semiautomated and high-precision ECG methodologies in seven thorough QT studies-implications for the power of studies intended for definitive evaluation of a drug's QT effect.
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- 2017
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- Publication type:
- journal article
Can Bias Evaluation Provide Protection Against False-Negative Results in QT Studies Without a Positive Control Using Exposure-Response Analysis?
- Published in:
- Journal of Clinical Pharmacology, 2017, v. 57, n. 1, p. 85, doi. 10.1002/jcph.779
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- Publication type:
- Article
Concentration-Response Modeling of ECG Data From Early-Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk - Experience From the Development Program of Lemborexant.
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- Journal of Clinical Pharmacology, 2017, v. 57, n. 1, p. 96, doi. 10.1002/jcph.785
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- Publication type:
- Article
Ascending Single-Dose, Double-Blind, Placebo-Controlled Safety Study of Noribogaine in Opioid-Dependent Patients.
- Published in:
- Clinical Pharmacology in Drug Development, 2016, v. 5, n. 6, p. 460, doi. 10.1002/cpdd.254
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- Article
Electrocardiographic Effects of a Supratherapeutic Dose of Oritavancin.
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- Clinical Pharmacology in Drug Development, 2016, v. 5, n. 6, p. 502, doi. 10.1002/cpdd.268
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- Publication type:
- Article
Evaluation of the QT effect of a combination of piperaquine and a novel anti-malarial drug candidate OZ439, for the treatment of uncomplicated malaria.
- Published in:
- British Journal of Clinical Pharmacology, 2015, v. 80, n. 4, p. 706, doi. 10.1111/bcp.12680
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- Article
Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14.
- Published in:
- 2015
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- Publication type:
- journal article
Effect of ceralifimod (ONO-4641) on lymphocytes and cardiac function: Randomized, double-blind, placebo-controlled trial with an open-label fingolimod arm.
- Published in:
- Journal of Clinical Pharmacology, 2015, v. 55, n. 9, p. 1051, doi. 10.1002/jcph.513
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- Publication type:
- Article
Detection of QTc Effects in Small Studies-Implications for Replacing the Thorough QT Study.
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- Annals of Noninvasive Electrocardiology, 2015, v. 20, n. 4, p. 368, doi. 10.1111/anec.12227
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- Publication type:
- Article
Effect of Ponesimod, a Selective S1P<sub>1</sub> Receptor Modulator, on the QT Interval in Healthy Individuals.
- Published in:
- Basic & Clinical Pharmacology & Toxicology, 2015, v. 116, n. 5, p. 429, doi. 10.1111/bcpt.12336
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- Article
Safety, pharmacokinetics, pharmacogenomics and QT concentration−effect modelling of the SirT1 inhibitor selisistat in healthy volunteers.
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- British Journal of Clinical Pharmacology, 2015, v. 79, n. 3, p. 477, doi. 10.1111/bcp.12513
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- Article
Erratum to: Albiglutide Does Not Prolong QTc Interval in Healthy Subjects: A Thorough ECG Study.
- Published in:
- Diabetes Therapy, 2014, v. 5, n. 2, p. 609, doi. 10.1007/s13300-014-0074-y
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- Publication type:
- Article
A thorough QT study in the context of an uptitration regimen with selexipag, a selective oral prostacyclin receptor agonist.
- Published in:
- Drug Design, Development & Therapy, 2014, v. 8, p. 175, doi. 10.2147/DDDT.S75565
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- Publication type:
- Article
Effect of lenvatinib (E7080) on the QTc interval: results from a thorough QT study in healthy volunteers.
- Published in:
- Cancer Chemotherapy & Pharmacology, 2014, v. 73, n. 6, p. 1109, doi. 10.1007/s00280-014-2444-6
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- Publication type:
- Article
Effect of lenvatinib (E7080) on the QTc interval: results from a thorough QT study in healthy volunteers.
- Published in:
- 2014
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- Publication type:
- Journal Article