Automated Prediction of First-in-man Dosing Using Pre-clinical PK Data

Humans differ from commonly used pre-clinical model organisms (rats, dogs, monkeys) in terms of their biochemistry, physiology, and anatomy. Predicting a drug’s pharmacokinetic (PK) profile in humans using animal PK data must account for these differences. Allometric scaling is used to predict human PK parameters based on animal data. While allometric scaling has been used in drug development for many years, it has historically been a very complicated and laborious process.

Certara scientists have developed a novel, fully automated application that can support critical decision making when designing a first-in-man clinical study based on pre-clinical data. In this webinar, Dr. Serge Guzy and Tinh Nguyen demonstrated how this application uses a population PK modeling approach to fit input data from multiple species, calculate PK model parameters for each species, and then extrapolate to humans based on a pre-defined allometric scaling equation. They then showed how the application can calculate optimal dosing scenarios based on user-defined drug exposure thresholds.