Nenad Sarapa

Summary

Affiliation: Pfizer Global Research and Development
Country: USA

Publications

  1. ncbi request reprint Electrocardiographic identification of drug-induced QT prolongation: assessment by different recording and measurement methods
    Nenad Sarapa
    Clinical Pharmacology, Pharmacia Corp, Kalamazoo, Michigan, USA
    Ann Noninvasive Electrocardiol 9:48-57. 2004
  2. ncbi request reprint The effect of mild and moderate hepatic impairment on the pharmacokinetics of valdecoxib, a selective COX-2 inhibitor
    Nenad 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
  3. ncbi request reprint 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 sotalol
    Anthony A Fossa
    Pfizer Global Research and Development, Groton, Connecticut 06340, USA
    Ann Noninvasive Electrocardiol 12:338-48. 2007
  4. pmc Effect of ketoconazole on the pharmacokinetics of axitinib in healthy volunteers
    Yazdi K Pithavala
    Pfizer Oncology, 10555 Science Center Drive, San Diego, CA 92121, USA
    Invest New Drugs 30:273-81. 2012
  5. ncbi request reprint 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 volunteers
    Nenad Sarapa
    Clinical Pharmacology, Pfizer Global Research and Development, San Diego, CA, USA
    J Clin Pharmacol 45:1198-205. 2005
  6. ncbi request reprint Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents
    Nenad Sarapa
    Johnson and Johnson PRD, Welsh and McKean Roads, Spring House, PA 19477 0776, USA
    Expert Opin Drug Saf 7:305-18. 2008
  7. ncbi request reprint Contrasting time- and rate-based approaches for the assessment of drug-induced QT changes
    Fabrice Extramiana
    Cardiology Department Lariboisière University Hospital, 2 rue Ambroise Parè 75010, Paris, France
    J Clin Pharmacol 47:1129-37. 2007
  8. ncbi request reprint Digital 12-lead Holter in the assessment of drug effects on cardiac repolarization
    Nenad Sarapa
    J Electrocardiol 38:293. 2005
  9. ncbi request reprint Identification of sotalol-induced changes in repolarization with T wave area-based repolarization duration parameters
    Jean Philippe Couderc
    Cardiology Unit, Heart Research Follow Up Program, University of Rochester, NY 14642, USA
    J Electrocardiol 36:115-20. 2003
  10. ncbi request reprint Valdecoxib, a COX-2-specific inhibitor, does not affect cardiac repolarization
    Nenad Sarapa
    Department of Clinical Pharmacology, Pharmacia Corporation, 5200 Old Orchard Road, Skokie, IL 60077, USA
    J Clin Pharmacol 43:974-82. 2003

Detail Information

Publications14

  1. ncbi request reprint Electrocardiographic identification of drug-induced QT prolongation: assessment by different recording and measurement methods
    Nenad 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...
  2. ncbi request reprint The effect of mild and moderate hepatic impairment on the pharmacokinetics of valdecoxib, a selective COX-2 inhibitor
    Nenad 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...
  3. ncbi request reprint 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 sotalol
    Anthony 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...
  4. pmc Effect of ketoconazole on the pharmacokinetics of axitinib in healthy volunteers
    Yazdi 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...
  5. ncbi request reprint 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 volunteers
    Nenad 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...
  6. ncbi request reprint Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents
    Nenad 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...
  7. ncbi request reprint Contrasting time- and rate-based approaches for the assessment of drug-induced QT changes
    Fabrice 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...
  8. ncbi request reprint Digital 12-lead Holter in the assessment of drug effects on cardiac repolarization
    Nenad Sarapa
    J Electrocardiol 38:293. 2005
  9. ncbi request reprint Identification of sotalol-induced changes in repolarization with T wave area-based repolarization duration parameters
    Jean 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...
  10. ncbi request reprint Valdecoxib, a COX-2-specific inhibitor, does not affect cardiac repolarization
    Nenad Sarapa
    Department of Clinical Pharmacology, Pharmacia Corporation, 5200 Old Orchard Road, Skokie, IL 60077, USA
    J Clin Pharmacol 43:974-82. 2003
    ....
  11. ncbi request reprint Implications of methodological differences in digital electrocardiogram interval measurement
    Fabio 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...
  12. ncbi request reprint Quality assessment of digital annotated ECG data from clinical trials by the FDA ECG Warehouse
    Nenad 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...
  13. ncbi request reprint Impaired T-amplitude adaptation to heart rate characterizes I(Kr) inhibition in the congenital and acquired forms of the long QT syndrome
    Jean 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...
  14. doi request reprint Quantitative performance of E-Scribe warehouse in detecting quality issues with digital annotated ECG data from healthy subjects
    Nenad 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...