Population pharmacokinetic and concentration--QTc models for moxifloxacin: pooled analysis of 20 thorough QT studies

• Published in: Journal of clinical pharmacology Vol. 51; no. 8; p. 1152
• Main Authors: Florian, Jeffry A, Tornøe, Christoffer W, Brundage, Richard, Parekh, Ameeta, Garnett, Christine E
• Format: Journal Article
• Language: English
• Published: England 01.08.2011
• Subjects: Administration, Oral; Adolescent; Adult; Aged; Animals; Anti-Infective Agents - administration & dosage; Anti-Infective Agents - adverse effects; Anti-Infective Agents - blood; Anti-Infective Agents - pharmacokinetics; Aza Compounds - administration & dosage; Aza Compounds - adverse effects; Aza Compounds - blood; Aza Compounds - pharmacokinetics; Clinical Trials as Topic; Delayed-Action Preparations - administration & dosage; Delayed-Action Preparations - adverse effects; Delayed-Action Preparations - pharmacokinetics; Drugs, Investigational - administration & dosage; Drugs, Investigational - adverse effects; Drugs, Investigational - analysis; Drugs, Investigational - pharmacokinetics; Electrocardiography - drug effects; Female; Fluoroquinolones; Humans; Intestinal Absorption; Male; Metabolic Clearance Rate; Middle Aged; Models, Biological; Quinolines - administration & dosage; Quinolines - adverse effects; Quinolines - blood; Quinolines - pharmacokinetics; United States; United States Food and Drug Administration; Young Adult; United States

To increase our understanding of important subject characteristics and design variables affecting the performance of oral moxifloxacin in thorough QT studies, population pharmacokinetic and concentration-QTc models were developed by pooling data from 20 studies. A 1-compartment model with first-orde...