Affiliation: Pfizer Global Research and Development
- Electrocardiographic identification of drug-induced QT prolongation: assessment by different recording and measurement methodsNenad Sarapa
Clinical Pharmacology, Pharmacia Corp, Kalamazoo, Michigan, USA
Ann Noninvasive Electrocardiol 9:48-57. 2004..Manual methods (digitizing pad and digital on-screen calipers) were compared for precision of QT and RR interval measurement...
- The effect of mild and moderate hepatic impairment on the pharmacokinetics of valdecoxib, a selective COX-2 inhibitorNenad Sarapa
Pfizer Global Research and Development, Clinical PK PD, 10777 Science Center Drive Blg 95, San Diego, CA 92130, USA
Eur J Clin Pharmacol 61:247-56. 2005..This study evaluated the effects of varying degrees of hepatic impairment on the pharmacokinetics and safety of valdecoxib following single and multiple dosing...
- Analyses of dynamic beat-to-beat QT-TQ interval (ECG restitution) changes in humans under normal sinus rhythm and prior to an event of torsades de pointes during QT prolongation caused by sotalolAnthony A Fossa
Pfizer Global Research and Development, Groton, Connecticut 06340, USA
Ann Noninvasive Electrocardiol 12:338-48. 2007..We examined whether analyses of sequential beat-to-beat QT and TQ interval measures can be used to quantify ECG restitution changes under normal sinus rhythm...
- Effect of ketoconazole on the pharmacokinetics of axitinib in healthy volunteersYazdi K Pithavala
Pfizer Oncology, 10555 Science Center Drive, San Diego, CA 92121, USA
Invest New Drugs 30:273-81. 2012..This study evaluated changes in axitinib plasma pharmacokinetic parameters and assessed safety and tolerability in healthy subjects, following axitinib co-administration with the potent CYP3A inhibitor ketoconazole...
- The application of accelerator mass spectrometry to absolute bioavailability studies in humans: simultaneous administration of an intravenous microdose of 14C-nelfinavir mesylate solution and oral nelfinavir to healthy volunteersNenad Sarapa
Clinical Pharmacology, Pfizer Global Research and Development, San Diego, CA, USA
J Clin Pharmacol 45:1198-205. 2005..Accelerator mass spectrometry microdosing reduces potential safety issues around dosing radioactivity to humans and prevents the need to formulate high intravenous doses...
- Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agentsNenad Sarapa
Johnson and Johnson PRD, Welsh and McKean Roads, Spring House, PA 19477 0776, USA
Expert Opin Drug Saf 7:305-18. 2008..Drug-induced QTc prolongation is becoming increasingly important in oncology since novel therapies result in prolonged survival of cancer patients already predisposed to cardiotoxicity...
- Contrasting time- and rate-based approaches for the assessment of drug-induced QT changesFabrice Extramiana
Cardiology Department Lariboisière University Hospital, 2 rue Ambroise Parè 75010, Paris, France
J Clin Pharmacol 47:1129-37. 2007..The "rate"-averaging process leads to a complete loss of the time course of drug effect. In conclusion, the individual correction formula calculated from the placebo condition cannot always be used for QT correction on the drug...
- Digital 12-lead Holter in the assessment of drug effects on cardiac repolarizationNenad Sarapa
J Electrocardiol 38:293. 2005
- Identification of sotalol-induced changes in repolarization with T wave area-based repolarization duration parametersJean Philippe Couderc
Cardiology Unit, Heart Research Follow Up Program, University of Rochester, NY 14642, USA
J Electrocardiol 36:115-20. 2003..In conclusion, morphological parameters of T wave are able to identify the changes in repolarization interval induced by sotalol. These parameters are more stable and thus more reliable than the traditional QT interval measurements...
- Valdecoxib, a COX-2-specific inhibitor, does not affect cardiac repolarizationNenad Sarapa
Department of Clinical Pharmacology, Pharmacia Corporation, 5200 Old Orchard Road, Skokie, IL 60077, USA
J Clin Pharmacol 43:974-82. 2003....
- Implications of methodological differences in digital electrocardiogram interval measurementFabio Badilini
AMPS LLC, New York, NY 10025, USA
J Electrocardiol 39:S152-6. 2006..A better understanding of the implications from different measurement methodologies will facilitate more informed choice of the appropriate method for ECG interval measurement on clinical trials...
- Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG WarehouseNenad Sarapa
Expert Opin Drug Saf 6:595-607. 2007..Automatic Warehouse algorithms assess the quality of QT annotation and duration of manual QT measurement by the central ECG laboratory...
- Impaired T-amplitude adaptation to heart rate characterizes I(Kr) inhibition in the congenital and acquired forms of the long QT syndromeJean Philippe Couderc
Heart Research Follow Up Program, Cardiology Department, University of Rochester Medical Center, Rochester, New York, USA
J Cardiovasc Electrophysiol 18:1299-305. 2007..In the search for alternative markers, we investigated the T-amplitude and QT interval adaptation to heart rate (HR) in patients with the congenital long QT syndrome (LQTS) and individuals with sotalol-induced QT prolongation...
- Quantitative performance of E-Scribe warehouse in detecting quality issues with digital annotated ECG data from healthy subjectsNenad Sarapa
Daiichi Sankyo Pharma Development, Edison, New Jersey, USA
J Clin Pharmacol 48:538-46. 2008..The E-Scribe Warehouse showed satisfactory performance in detecting electrocardiogram quality issues that may impair reliability of QTc assessment in clinical trials in healthy subjects...