Case Study: Alkermes predicts hepatic impairment and DDI risk with Certara's Simcyp PBPK modeling

Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy

The customer, Alkermes, needed to assess the drug-drug interaction (DDI) risk and the impact of hepatic impairment on its combination therapy for schizophrenia without conducting new clinical trials. They engaged vendor Certara to address this challenge using their Simcyp PBPK Simulator.

Certara implemented a validated physiologically-based pharmacokinetic (PBPK) model to predict the drug's behavior. The solution successfully predicted that no DDI would occur between the two combined drugs and quantified the expected increase in drug exposure for patients with impaired liver function. This use of PBPK modeling by Certara provided Alkermes with the necessary evidence for regulatory approval without requiring additional, difficult-to-conduct clinical studies.

Alkermes