Use M&S tools (PopPK, PKPD, Simulation) to make the most of your clinical studies data
Population PK, PKPD and simulations to better design your clinical program.
Modeling and Simulation (M&S) is a combination of tools (PopPK, PKPD and simulation) to optimize your clinical development. These techniques are used to make the most of the clinical studies data and make the best predictions and simulations.
- Population PK: PopPK is used to describe the time course of drug exposure in the subject and to investigate sources of variability among individuals in target populations receiving the drug, through a unified model including simultaneously all data from all individuals.
- PKPD modeling: The relation between drug levels and drug effects on a population can also be characterized through PKPD modeling, simultaneously or independently from the PopPK.
- Simulation: The developed models incorporating subjects’ variability can be used to simulate alternative dose regimens and anticipate drug’s effects, through PKPD models, before study conduct.
M&S advantages for marketing authorization
- Understand relevant pharmacokinetic information and structural relation with drug effects in the target population.
- Identify factors that may influence the pharmacokinetic behavior of a drug.
- Define the optimum dosing strategy for a population, subgroup, or individual patient.
- Provide strategic prior information when the clinical data is sparse, such as in cases for the elderly, pediatrics or orphan (rare) drugs.