Pharmacological, mathematical, and statistical methodologies to characterise exposure-response relationships as a basis for determining the best dosing regimen.
The pharmacokinetic and pharmacodynamic (PK/PD) index, magnitude of the PK/PD index, population PK models and probability of target attainment (PTA) are used to predict the best dose for late-stage clinical trials. Robust clinical PK/PD analyses also require an accompanying robust non-clinical PK/PD package.
See also dosing and dose fractionation study.
Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (CPT: Pharmacometrics & Systems Pharmacology, 2017)
Report from Dose Finding Workshop (European Medicines Agency, 2015)
Considerations for Dose Selection and Clinical Pharmacokinetics/Pharmacodynamics for the Development of Antibacterial Agents (Antimicrobial Agents and Chemotherapy, 2019)
REVIVE Webinar: ‘PK-PD in support of accelerated programmes for antimicrobial development: how much is enough?’ by William Hope (GARDP, 2018)
REVIVE Webinar: ‘Models for antimicrobial R&D: Computational modelling for population PK and PKPD’ by Lena Friberg & Elisabet Nielsen (GARDP, 2019)