Population PK is the study of relationships between pharmacokinetic parameters and the variability in drug absorption, distribution, metabolism, and excretion across a diverse population of patients receiving a therapeutic agent. Population PK analyses are typically conducted within or across larger studies (e.g., Phase 2 and 3) to explain variability by identifying factors of demographic, environmental, pathophysiologic, or concomitant drug-related origin that may influence the pharmacokinetic behavior of an investigational drug. Ultimately, the goal of population PK is to establish dosing guidelines for different patients, which is critical information to satisfy requirements for marketing applications and to provide to physicians for appropriate treatment of patients.

ClinPharm Consulting’s population PK services include:

• Clinical protocol design to ensure collection of relevant information to use in population PK analyses.
• Clinical operations support to ensure PK data and important clinical covariates are collected and handled properly by investigational sites.
• Liaison services with bioanalytical facilities and clinical data management groups to ensure data is captured and reported properly for population PK analyses.
• Comprehensive population PK analyses using industry leading software (NONMEM).
• Data management services for PK data to ensure compliance with current CDISC standards.
• Superior writing capabilities to prepare complete population PK reports that highlight the most salient information obtained from the analyses.

Population PK modeling is an integral part of drug development. Along with ClinPharm’s extensive experience in traditional PK analyses (i.e., those typically conducted in Phase 1 studies involving a small number of healthy volunteers), expansion into population PK allows ClinPharm to be a complete and cost-effective resource for clients throughout all clinical phases of drug development.