Search Results - "Kleiman, Robert B"

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 by Kleiman, Robert B., Darpo, Borje, Thorn, Michael, Stoehr, Thomas, Schippers, Frank

“…Aims Remimazolam is a new, ultra‐short‐acting benzodiazepine developed for intravenous (IV) use during procedural sedation and in general anaesthesia. Two…”
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Ventricular Arrhythmias Associated With Over-the-Counter and Recreational Opioids by Krantz, Mori J., Rudo, Todd J., Haigney, Mark C.P., Stockbridge, Norman, Kleiman, Robert B., Klein, Michael, Kao, David P.

“…Epidemic increases in opioid deaths prompted policies limiting access to prescription opioids in North America. Consequently, the over-the-counter opioids…”
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Evaluation of the Effect of SPN-812 (Viloxazine Extended-Release) on QTc Interval in Healthy Adults by Nasser, Azmi, Faison, Shamia L, Liranso, Tesfaye, Adewole, Toyin, Busse, Gregory D, Fava, Maurizio, Kleiman, Robert B, Schwabe, Stefan

“…To assess the effects of a supratherapeutic dose of SPN-812, a drug currently under investigation as a treatment for attention-deficit/hyperactivity disorder,…”
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False Negative ECG Device Results May Increase the Risk of Adverse Events in Clinical Oncology Trials by Dekie, Luc, Kleiman, Robert B

“…Sites participating in clinical trials may not have the expertise and infrastructure to accurately measure cardiac intervals on 12-lead ECGs and rely heavily…”
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Improving the in Vivo QTc assay: The value of implementing best practices to support an integrated nonclinical-clinical QTc risk assessment and TQT substitute by Vargas, Hugo M., Rossman, Eric I., Wisialowski, Todd A., Nichols, Jill, Pugsley, Michael K., Roche, Brian, Gintant, Gary A., Greiter-Wilke, Andrea, Kleiman, Robert B., Valentin, Jean-Pierre, Leishman, Derek J.

“…Recent updates and modifications to the clinical ICH E14 and nonclinical ICH S7B guidelines, which both relate to the evaluation of drug-induced delayed…”
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Intracellular uptake of agents that block the hERG channel can confound the assessment of QT interval prolongation and arrhythmic risk by Burashnikov, Alexander, Barajas-Martinez, Hector, Cox, Robert, Demitrack, Mark A., Fossler, Michael J., Kramer, Michael, Kleiman, Robert B., Kowey, Peter, Antzelevitch, Charles

“…Oliceridine is a biased ligand at the μ-opioid receptor recently approved for the treatment of acute pain. In a thorough QT study, corrected QT (QTc)…”
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Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As by Rossman, Eric I., Wisialowski, Todd A., Vargas, Hugo M., Valentin, Jean-Pierre, Rolf, Michael G., Roche, Brian M., Riley, Steve, Pugsley, Michael K., Nichols, Jill, Li, Dingzhou, Leishman, Derek J., Kleiman, Robert B., Greiter-Wilke, Andrea, Gintant, Gary A., Engwall, Michael J., Delaunois, Annie, Authier, Simon

“…The ICH E14/S7B Questions and Answers (Q&As) guideline introduces the concept of a “double negative” nonclinical scenario (negative hERG assay and negative in…”
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ICH E14 Q&A(R2) document: commentary on the further updated recommendations on thorough QT studies by Shah, Rashmi R., Morganroth, Joel, Kleiman, Robert B.

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Replacing the thorough QT study: reflections of a baby in the bath water by Kleiman, Robert B., Shah, Rashmi R., Morganroth, Joel

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Long-term Electrocardiographic Safety Monitoring in Clinical Drug Development: A Report from the Cardiac Safety Research Consortium by Piccini, Jonathan P, Clark, Richard L, Kowey, Peter R, Mittal, Suneet, Dunmon, Preston, Stockbridge, Norman, Reiffel, James A, Turakhia, Mintu P, Ziegler, Paul D, Kleiman, Robert B, Ismat, Fraz, Sager, Philip

“…This White Paper, prepared by members of the Cardiac Safety Research Consortium (CSRC), discusses important issues regarding scientific and clinical aspects of…”
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Thorough QT/QTc Evaluation of the Cardiac Safety of Enarodustat (JTZ‐951), an Oral Erythropoiesis‐Stimulating Agent, in Healthy Adults by Pai, Sudhakar M., Yamada, Hiroyuki, Kleiman, Robert B., Zhuo, Rui, Huang, Qingtao (Mike), Koretomo, Ryosuke

“…This study evaluated the effect of enarodustat on cardiac repolarization in healthy subjects. Enarodustat (20 and 150 mg [supratherapeutic dose]), placebo, and…”
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A thorough QT study to assess the effects of tbo-filgrastim on cardiac repolarization in healthy subjects by Adar, Liat, Avisar, Noa, Lammerich, Andreas, Kleiman, Robert B, Spiegelstein, Ofer

“…Tbo-filgrastim is a recombinant human granulocyte colony-stimulating factor approved by the US Food and Drug Administration to reduce the duration of severe…”
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Intracellular Uptake of Agents That Block the hERG Channel Can Confound Assessment of QT Prolongation and Arrhythmic Risk by Burashnikov, Alexander, Barajas-Martinez, Hector, Cox, Robert, Demitrack, Mark A., Fossler, Michael J., Kramer, Michael, Kleiman, Robert B., Kowey, Peter, Antzelevitch, Charles

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A Novel Approach to QTc Studies: Assessing Cardiac Safety of the mTOR Kinase Inhibitor CC-223 within the Dose-Escalation/Expansion Study by Kleiman, Robert B, Chopra, Rajesh, Hans, de Haan, Hege, Kristen, James, Angela J, Wang, Xiaomin, Wu, Xiaoling, O'Mara, Edward

“…Introduction: A variety of chemically diverse drugs are known to alter cardiac repolarization and to produce sudden cardiac death. Current regulatory…”
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Endocardial mapping during sinus rhythm in patients with coronary artery disease and nonsustained ventricular tachycardia by Buxton, Alfred E., Kleiman, Robert B., Kindwall, K.Elizabeth, Josephson, Mark E.

“…Programmed stimulation in patients with nonsustained ventricular tachycardia (VT) and coronary artery disease (CAD) induces sustained VT in 30 to 50% of…”
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Acute and chronic cycle length dependent increase in ventricular pacing threshold by Hook, B G, Perlman, R L, Callans, D J, Hanna, M S, Kleiman, R B, Flores, B T, Marchlinski, F E

“…Several factors have been shown to influence ventricular pacing threshold in humans, including pacing lead location (endocardial vs epicardial), lead…”
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Implantable cardioverter-defibrillator therapy in the absence of significant symptoms : rhythm diagnosis and management aided by stored electrogram analysis by HOOK, B. G, CELLANS, D. J, KLEIMAN, R. B, FLORES, B. T, MARCHLINSKI, F. E

“…This report describes the value of stored ventricular electrogram analysis in the diagnosis and management of patients experiencing minimal or no symptoms…”
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Unique sensing errors in third-generation implantable cardioverter-defibrillators by Callans, David J., Hook, Bruce G., Kleiman, Robert B., Mitra, Raman L., Flores, Belinda T., Marchlinski, Francis E.

“…Objectives. Third-generation cardioverter-defibrillators appear to be susceptible to unique sensing errors. This study was performed to determine the incidence…”
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Comparison of simultaneous versus sequential defibrillation pulsing techniques using a nonthoracotomy system by Hsia, H H, Kleiman, R B, Flores, B T, Marchlinski, F E

“…The defibrillation threshold (DFT) using simultaneous (SIML) versus sequential (SEQ) pathways for shock delivery was compared in 16 patients with an implanted…”
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Electrophysiologic and mechanical properties of single feline RV and LV myocytes by Kleiman, R B, Houser, S R

“…With the advent of techniques to isolate large numbers of single adult mammalian ventricular myocytes, it has become possible to determine whether, as a result…”
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