Pharmacokinetic Modeling Supports the Approval of a Rare Liver Disease Treatment

Certara scientists deliver an integrated solution that helps Intercept Pharmaceuticals achieve FDA approval for Ocaliva. Intercept Pharmaceuticals needed to develop a dosing strategy for obeticholic acid (OCA) to treat patients with primary biliary cholangitis (PBC).

Certara scientists used Phoenix NLME to build a physiologic PK model to define the relationship between systemic and hepatic exposure of OCA in PBC patients with and without liver impairment.

Modeling results demonstrated the safety and efficacy of the OCA dosing regimen in PBC patients with and without cirrhosis.