The application ofin vitrosurveillance data for antibacterial dose selection


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Abstract

HIGHLIGHTSIn vitro surveillance data are a key input for PK-PD target attainment analyses.Study design should consider pathogens, sample size, and target patient populations.Surveillance data are essential during antibacterial drug development and post approval.In vitro surveillance data, which provide key information to interpret the results of pharmacokinetic/pharmacodynamics (PK-PD) target attainment studies, are used to support dose selection decisions and recommendations for in vitro susceptibility testing criteria for antibacterial agents during drug development. Considerations for designing the in vitro surveillance database to support the development of antibacterial agents include the choice of pathogens to study, the sample size of isolate collections needed, and target patient populations from which clinical isolates should be collected. Post-approval, global in vitro surveillance data produced by reference quality antibacterial susceptibility tests together with PK-PD target attainment analyses provide the opportunity to evaluate approved and clinically used antibacterial dosing regimens. These data enable the optimal use of antibacterial agents in an environment in which we face changing and challenging bacterial pathogens.

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