Reevaluation of moxifloxacin pharmacokinetics and their direct effect on the QT interval

Journal of Clinical Pharmacology

Volumn 52, Issue 3, 2012, Pages 329-338

  Grosjean, Philippe ^a,c   Urien, Saïk ^b,c  

^a SANOFI   (France)

^b INSERM   (France)

^c UNIVERSITÉ PARIS DESCARTES   (France)

Author keywords

concentration response; Moxifloxacin; pharmacokinetic pharmacodynamic modeling; QT interval

Indexed keywords

MOXIFLOXACIN;

ADULT; ARTICLE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFECT; FEMALE; HUMAN; HUMAN EXPERIMENT; LEAN BODY WEIGHT; MALE; MODEL; NORMAL HUMAN; QT INTERVAL; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ADULT; ANTI-INFECTIVE AGENTS; ARRHYTHMIAS, CARDIAC; AZA COMPOUNDS; BODY COMPOSITION; BODY WEIGHT; ELECTROCARDIOGRAPHY; FEMALE; HEART RATE; HUMANS; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; QUINOLINES; TISSUE DISTRIBUTION; YOUNG ADULT;

EID: 84860136207     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270011398361     Document Type: Article

References (15)

1. The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (ICH E14). International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ; 2005 ; 2005..
2. Garnett C, Beasley N, Bhattaram VA, et al. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol. 2008 ; 48: 13-18
3. Russell T, Riley SP, Cook JA, Richard L, Lalonde RL. A perspective on the use of concentration-QT modeling in drug development. J Clin Pharmacol. 2008 ; 48: 9-12
4. Bloomfield D, Krishna R. Commentary on the clinical relevance of concentration/QTc relationships for new drug candidates. J Clin Pharmacol. 2008 ; 48: 6-8
5. West Haven, Conn: Bayer Pharmaceuticals ; 2003 :
6. Mason JW, Florian JA, Garnett CE, et al. Pharmacokinetics and pharmacodynamics of three moxifloxacin dosage forms: implications for blinding in active-controlled cardiac repolarization studies. J Clin Pharmacol. 2010 ; 50: 1249-1259
7. Savic RA, Jonker DM, Kerbusch T, Karlsson MO. Implementation of a transit compartment model for describing drug absorption in pharmacokinetic studies. J Pharmacokinet Pharmacodyn. 2007 ; 34: 711-726
8. Piotrovsky V. Pharmacokinetic-pharmacodynamic modeling in the data analysis and interpretation of drug-induced QT/QTc prolongation. AAPS J. 2005 ; 7: E609 - E624
9. Kuhn E, Lavielle M. Maximum likelihood estimation in nonlinear mixed effects models. Comput Stat Data Anal. 2005 ; 49: 1020-1030
10. R (2009): A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing ; 2009 :
11. Green B, Duffull SB. What is the best size descriptor to use for pharmacokinetic studies in the obese?. Br J Clin Pharmacol. 2004 ; 58 (2). 119-133
12. Moise PA. Pharmacokinetics and metabolism of moxifloxacin. Drugs of Today. 2000 ; 36: 229-244
13. Sullivan TJ, Lettieri TJ, Liu P, Heller A. The influence of age and gender on the pharmacokinetics of moxifloxacin. Clin Pharmacokinet. 2001 ; 40 (suppl 1). 1-18
14. Drici MD. Influence of gender on drug-acquired long QT syndrome. Eur Heart J Suppl. 2001 ; 3 (suppl K). K41 - K47
15. Bazzoli C, Retout S, Mentré F. Design evaluation and optimisation in multiple response nonlinear mixed effect models: PFIM 3.0. Comput Methods Programs Biomed. 2010 ; 98: 55-65