Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study
In the heavily regulated pharmaceutical industry, changes to the manufacturing process can be quite complex and costly. This is especially true when moving production from one location to another.
Per the FDA guidance, “Studies to establish bioequivalence (BE) between two products are important for certain formulation or manufacturing changes occurring during the drug development and post approval stages. In BE studies, the exposure profile of a test drug product is compared to that of a reference drug product.”
In this case study, the sponsor’s closing of a manufacturing site required that one of its top-selling products be made at a different facility, triggering FDA to request they demonstrate BE on that product. FDA suggested the sponsor might be able to leverage Physiologically based Pharmacokinetics (PBPK) to demonstrate BE versus re-running the original BE study.