The State of the Art in Approaches for Predicting Human PK for Small Molecule Development Candidates
Accurate prediction of human clearance (CL) and volume of distribution at steady state (Vd,ss) for small molecule drug candidates is an essential
component of assessing likely efficacious dose and clinical safety margins. In 2021, the IQ Consortium Human PK Prediction Working Group undertook a survey of IQ member companies to understand the current PK prediction methods being used to estimate these parameters across the pharmaceutical industry.
This webinar will discuss the heterogeneity in approaches being used across the industry which could lead to different PK predictions with the same input data, for example:
- Differences in allometric approaches
- Differing incorporation of binding terms
- Inconsistent use of empirical correction factors for in vitro-in vivo extrapolation (IVIVE)
The survey also revealed a broad interest in improving human PK predictions by identifying the most appropriate compound-class-specific methods, as determined by physiochemical properties and knowledge of CL pathways.
Furthermore, there was consensus that increased understanding of the uncertainty inherent to the compound class-dependent prediction would be invaluable in aiding communication of human PK and dose uncertainty at the time of candidate nomination for development. We will also share how the human PK Prediction Working Group is utilizing these survey findings to help interrogate clinical IV datasets from across the IQ consortium member companies.
This webinar is open to the general public. IQ membership is not required to register.