Non-clinical pharmacokinetic/pharmacodynamic (PK/PD) analysis is the study of how a drug’s exposure (PK) relates to its biological or antimicrobial effect (PD) using in vitro systems and animal models before human testing. It integrates data on drug absorption, distribution, metabolism, excretion (ADME), and target-site concentrations with measures of antimicrobial activity, such as minimum inhibitory concentration (MIC), time–kill kinetics, or bacterial burden reduction. These analyses help characterise exposure–effect relationships, identify PK/PD indices that best predict efficacy and define dose–response patterns across different infection models.
Non-clinical PK/PD analysis supports the selection of candidate compounds, optimization of dosing regimens, and early assessment of resistance suppression. It also informs translational modelling and dose projections for first-in-human and later clinical studies. Regulatory agencies increasingly rely on these data to guide antibacterial drug development, refine dose justification, and evaluate the likelihood that proposed regimens will achieve therapeutic targets in clinical populations.