Scientists at Certara and AstraZeneca developed PBPK models to determine dosing regimens for adolescents and older children using quetiapine XR formulations.
FDA scientists analyzed the predictive performance of Simcyp PBPK modeling and simulation for four drugs.
The Simcyp Simulator improves decision-making regarding the need for clinical studies in obese subjects.
Certara’s PKS Online enabled PKPD Bioscience Inc to become regulatory compliant and enhanced partnering with pharma companies.
To support filings, a client engaged Certara’s Synchrogenix division as a single-source solution to ensure consistency and adhere to regulatory requirements.