Use of pharmacokinetic-pharmacodynamic target attainment analyses to support phase 2 and 3 dosing strategies for doripenem.
A doripenem population pharmacokinetic model and Monte Carlo simulations were utilized for dose regimen decision support for future clinical development. Simulation results predict that 500 mg of doripenem administered over 1 h every 8 h would be effective against bacterial strains with MICs less than 2 microg/ml and that less susceptible strains could be treated with prolonged infusions.
Bhavnani
Sujata M
SM
Cognigen Corporation, Buffalo, NY, USA. SBhavnani-ICPD@OrdwayResearch.org
Hammel
Jeffrey P
JP
Cirincione
Brenda B
BB
Wikler
Matthew A
MA
Ambrose
Paul G
PG
D000293:Adolescent; D000328:Adult; D000368:Aged; D001419:Bacteria / Q000187:drug effects; D001424:Bacterial Infections / Q000382:microbiology; D015780:Carbapenems / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D000077726:Doripenem; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D008954:Models, Biological; D015233:Models, Statistical; D009010:Monte Carlo Method
D015780:Carbapenems; D000077726:Doripenem