Certara Simcyp receives FDA grants for advanced pharmacokinetic modelling
29 August 2023 -

Biosimulation specialist Certara (Nasdaq:CERT) announced on Tuesday that the Simcyp group has been awarded two grants from the US Food and Drug Administration (FDA) to expand its predictive models for assessing virtual bioequivalence (VBE) of drugs and to create a formulation toolbox for topical drug absorption.

The focus lies in enabling safer, faster and more cost-effective product development of both complex generics and novel drugs.

"The Simcyp Simulator has already proved its ability to replace clinical studies in both VBE and dermal absorption," said Rob Aspbury, president of Certara, Scientific Software. "These new grants will further demonstrate the predictive performance and reliability of biosimulation for improving patient health."

For virtual bioequivalence, the grant will facilitate the automation of trial simulations using mechanistic physiologically-based pharmacokinetic (PBPK) modelling, enabling the reduction or replacement of clinical trials. This involves developing verified workflows and case studies to foster wider industry and regulatory adoption.

Dermal PBPK modelling will be harnessed to predict drug absorption of topical formulations into the skin in virtual populations. This grant supports the creation of a robust dermal PBPK model integrated with a specialized formulation toolbox, enhancing decision-making and promoting efficient and cost-effective development of generic drug products.