Population pharmacokinetic, PK/PD, and exposure-response modeling are the industry standard approaches for modeling clinical, and increasingly non-clinical, pharmacological and safety and efficacy data to inform clinical trial program design and data analysis and interpretation. This meets regulatory requirements and expectations through all drug development phases to submission and beyond. Population PK, or PK/PD modeling uses PK or PD time course data from multiple subjects, potentially across many trials, to describe and simulate the dose, concentration (and PD) time relationship, accounting for the variability in the population. Exposure-response modeling quantifies and simulates the relationships between drug dose, exposure and efficacy or safety endpoints.
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