Understanding how antimicrobial exposure relates to effect (specifically the PK/PD index driving the antibacterial effect) is central to identifying effective dose regimens and supporting translation into patients. The resources in this theme cover the design and interpretation of in vitro, cellular and animal PK/PD studies, including approaches for combination therapies. They also show how human PK prediction, population modelling and probability-of-target-attainment analyses can be used to establish PK/PD targets, account for variability and guide dose selection.
Resources
9 resourcesReviews key factors for generating robust PK/PD data in murine models, highlighting variability, data interpretation, and study design.
Explores methods to estimate human pharmacokinetics and dose from in vitro and in vivo models to develop effective antimicrobials.
Addresses the role of pharmacokinetics and pharmacodynamics in antimicrobial drug development. The EMA guidelines on the use of PK/PD and basic studies to inform dose finding strategies are discussed. Advice is provided on realistic benchmarking, endpoints, and interpretation of study results.
Discusses the challenges of treating intracellular infections, highlighting the importance of cellular PK/PD parameters and in vitro models for evaluating the intracellular activity and efficacy of antibiotics.
Introduces how population PK and PK/PD modelling can be used to characterise drug exposure, preclinical efficacy, and interpatient variability, supporting translational strategies and individualised dosing.
Explores the challenges and new approaches in studying PK/PD for fixed-dose beta-lactam/beta-lactamase inhibitor combinations, focusing on insights gained from preclinical models.
Provides an overview of probability of target attainment (PTA), explaining its calculation, data requirements, and role in guiding dose selection during drug development.
Explores the principles of PK-PD modelling, designing PK-PD studies and evaluating PD endpoints with non-invasive imaging.
Outline regulatory guidelines on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products.