Population PK (popPK) analysis involves the use of models of drug concentration (pharmacokinetic) and/or drug response (pharmacodynamic) over a time period to understand how different factors influence the body’s interaction with a drug and vice versa. Population PK modeling and clinical trial simulations are an integral part of overall drug development but these analyses are complex and generally require a large & extensive effort from experts in the field (called pharmacometricians). Nuventra has a expert team of pharmacometricians lead by our Senior Vice President of Modeling and Simulation, Mark Sale, MD. We take complex population PK/PD analyses and make them understandable and usable for common sense drug development.
- Industry leading pharmacokineticists able to provide superior advice for modeling PK and pharmacokinetic/pharmacodynamic relationships.
- Rational selection of the most salient model for a given investigational compound and disease area.
- Comprehensive population PK (pop PK) analyses conducted using NONMEM.
- Use of Pharsight Phoenix NLME for specific population PK analyses.
- Access to cutting-edge population PK and PK/PD analysis tools and methodology.
- Clear guidance from an experienced consultant regarding the practical interpretation of population PK and PK/PD analyses.
- Superior population PK report writing capabilities to prepare complete pop PK reports that highlight the most salient information obtained from the analyses.
Operational Considerations for Clinical Trials Involving Population PK/PD
Nuventra can help clients with operational aspects of collecting data for population PK/PD analyses from sites involved in the conduct of Phase 2 and 3 studies. From our experience, prospective planning for collection of PK samples and important covariates will pay large dividends to clients by allowing for proper and robust analysis using our PK software packages.
Nuventra can help with the following operational aspects related to population PK/PD:
- Clinical protocol design to ensure collection of relevant and salient information for use in population PK/PD analyses.
- Clinical operations support to ensure PK/PD 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.