Category: Case Study
Rapid US & EU Opportunity Assessment of an Orphan Disease Therapeutic
Modeling and Analysis to support early decision-making and regulatory submission for a TB antibiotic
Supporting the Approval of a Treatment for a Neglected Tropical Disease
Scaling to support a BLA that grew 8x larger than originally planned
Controlling Polymer Change for Extended Release Formulation with PBPK
Using PBPK for a Formulation Change for Pediatric Patients (Tablet to Suspension)
Certara used PBPK to change the formulation and gain regulatory approval for a suspension formulation of a drug, expanding its usage to children.