Certara, a biosimulation company, reported that the Simcyp group has been awarded two new grants from the U.S. FDA to expand its predictive models for assessing drug virtual bioequivalence (VBE) and to create a formulation toolbox for topically applied drugs. These capabilities aim to enable safer, faster, and more cost-effective product development of both complex generics and novel drugs.

Bioequivalence (BE) studies, which are used to show that the rate and extent of absorption of the investigational product are not significantly different from those of the comparable reference drug product, can be costly and time-consuming. VBE trial simulations, using mechanistic Physiologically-Based Pharmacokinetic (PBPK) modeling, aim to address this challenge by simulating realistic virtual cohorts of patients to reduce and or replace clinical trials.

The grant will support increased automation of this process by developing verified workflows and multiple case studies to increase wider adoption of VBE by industry and regulators.

Dermal PBPK modeling has been applied to the development of topical formulations by predicting drug absorption into the skin in virtual populations. Topical products undergo changes immediately upon application due to formulation metamorphosis, which may alter the critical characteristics of the formulations.

The grant will also support the development and verification of a reliable and robust dermal PBPK model enhanced with the specialized dermal formulation toolbox to aid decision-making and result in lower risk, more efficient and cost-effective development of generic drug products.

“We are proud to collaborate with the FDA in developing innovative model-informed approaches for accelerating drug development of complex generic and innovator drugs,” said Rob Aspbury, President of Certara, Scientific Software. “The Simcyp Simulator has already proved its ability to replace clinical studies in both VBE and dermal absorption. These new grants will further demonstrate the predictive performance and reliability of biosimulation for improving patient health.”