A global, Tier 1 pharmaceutical company engages Phoenix Technology Services to develop a new solution that streamlines designing early clinical studies based on pre-clinical data.
Humans have a distinct biochemistry, anatomy, and physiology compared to other animals. Predictions of a drug’s PK profile in humans based on animal PK data must account for these differences. Allometric scaling is used to predict differences in PK parameters based only on size.
Getting the dose right for FIM trials is critical. Allometric scaling calculations are performed frequently in pre-clinical groups as they study various drugs in different model organisms. To help accelerate the pace of drug development for the client, Certara’s Phoenix Technology Services developed an application that automates FIM allometric scaling using pre-clinical PK data.