Certara replaces in-vivo clinical studies for complex generic drug

Virtual bioequivalent was successfully used for FDA abbreviated new drug application (ANDA) approval

Image from company website

Certara technology has successfully replaced in-vivo, clinical studies in an FDA abbreviated new drug application (ANDA) approval. The US company creates model-informed drug development technology.

This virtual bioequivalence for a complex generic drug was achieved using the Simcyp physiologically-based pharmacokinetic (PBPK) modelling and simulation platform.

Simcyp President and Managing Director Steve Toon, said: “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.”

“This approach also benefits patients by supporting the FDA’s mission to provide affordable quality products through increasing competition and extending the playing field,” Toon added.

Certara CEO, Professor Amin Rostami, said that the milestone is an excellent addition to the many scientific and regulatory accomplishments that Simcyp has achieved during the past 20 years

Bioequivalence studies

BE studies are conducted to ensure that the rate and extent of absorption of test drug products are not significantly different from that of the comparable reference drug products.

Changes in the manufacturing process/site, raw material supplier or minor adjustments to the drug formulation, also require evaluation of BE to demonstrate that such changes do not substantially change its in vivo performance.

Virtual bioequivalence leverages advanced modelling 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.

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