Drugs

‘Virtual Bioequivalence’ Modeling Used in Complex Generic OK

Certara says its Simcyp physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) in an undisclosed complex generic drug ANDA that was approved recently. “This drug approval represents a breakthrough for the industry and will help usher in a new era in which complex generic drugs and treatments with alternative delivery methods and formulations can be brought to patients more quickly, without compromising their safety,” Certara says.

The company says that “virtual bioequivalence” provides an ideal application for Simcyp’s PBPK modeling and simulation capabilities. “This approval demonstrates the boundless opportunities for innovation using PBPK across the entire spectrum of new, alternative and reformulated drug products,” it says. “Virtual bioequivalence leverages advanced modeling and simulation to not only demonstrate BE, but also provide additional insight into drug performance. These in silico studies are safer (removing the need for drug administration to, often, young healthy volunteers), faster and less expensive to conduct than clinical BE studies and represent an important advance for generic and innovator drug companies alike.”

For years, FDA has backed Certara’s research into the in-silico evaluation of bioequivalence and bioavailability. The agency in 2014 awarded the company a grant to further develop and verify the Simcyp Simulator’s Multi-Phase Multi-Layer Mechanistic Dermal Absorption model, MPML MechDermA, specifically to assess the bioequivalence of drugs absorbed through the skin, while also factoring in variability in specific populations. In 2016, it was awarded an additional FDA grant to create and verify a PBPK modeling and simulation framework to predict the behavior of complex, supersaturating drug products in the human body.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome