Certara's PBPK Model Accepted by FDA for New Drug Application
Certara announced its Simcyp Simulator enabled physiologically-based pharmacokinetic, PBPK, modeling predictions accepted by the U.S. FDA in lieu of clinical studies to support the new drug application for asciminib. PBPK modeling uses virtual biological systems to predict how drugs are absorbed, distributed, metabolized, and eliminated by the body, and is increasingly being applied in place of certain clinical studies where appropriate. The results published in "Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib," highlight the growing impact and business benefits of model-informed drug development approaches for regulatory decision-making.
