Population Pharmacokinetic (PopPK) Modeling Solutions

Population Pharmacokinetic (PopPK) analysis is used to inform drug development and drug use by quantifying and explaining observed variability in drug concentrations within a population.  Whether intrinsic or extrinsic sources, a firm understanding of this variability is necessary in order to determine if clinical management strategies or personalized dosing -- putting the patient first – is warranted and this can be accomplished using Population PK modeling.

The pharmacokinetics of your drug can be as diverse as the target population for your indication.  Covariate information such as age, gender, weight, race, hepatic or renal function can greatly influence the PK variability within any given population.  As drug efficacy and safety can be altered as a direct result of changes in your drug’s pharmacokinetics, quantification and understanding of the relationships between any multitude of covariates and exposure will enable appropriate dosing adjustments to be made – a clear benefit to your patients.  Using the industry standard software platform (NONMEM) coupled with Parexel’s integrated data management and quality systems, our experienced team of modelers will work with you to deepen your mechanistic understanding of your drug,

Contact our experienced pharmacometricians to collaborate with your team to develop and apply PopPK analysis to your drug’s development program.  Specific applications and benefits to your development program can be:

1. Selection of doses for clinical trials – allometric scaling for FIH
2. Support efficacy and safety with the addition of PD data
3. Design of pediatric studies