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Sino Biological - Cytokine

Certara Simcyp™ Group Granted Two New Awards by the US FDA

Wednesday, August 30, 2023

Certara, listed on Nasdaq as CERT, an influential figure in the field of biosimulation, has recently disclosed that the Simcyp group is the recipient of two novel grants from the U.S. Food and Drug Administration (FDA). These grants have been allocated to bolster the expansion of the group's predictive models, focusing on evaluating the virtual bioequivalence (VBE) of drugs, and to craft a toolbox tailored to formulations of topically administered drugs. The primary objective of these endeavors is to facilitate a more efficient and secure drug development process for both complex generic drugs and pioneering pharmaceuticals.

Rob Aspbury, at the helm of Certara's Scientific Software branch, expressed his enthusiasm for partnering with the FDA to spearhead inventive model-informed strategies that expedite the development of intricate generic drugs and novel pharmaceuticals. Aspbury underscored the track record of the Simcyp Simulator in substituting traditional clinical studies for both virtual bioequivalence assessments and dermal absorption evaluations. The recently secured grants will serve to further validate the dependability and effectiveness of biosimulation in its contribution to enhancing patient well-being.

Bioequivalence studies, essential for demonstrating that the rate of absorption of an investigative drug aligns with that of a corresponding reference drug, often prove to be resource-intensive and time-demanding. The concept of virtual bioequivalence trial simulations, powered by mechanistic physiologically-based pharmacokinetic (PBPK) modeling, extends a potential solution by virtually simulating diverse patient cohorts. This innovative approach aims to significantly curtail or even replace the necessity for exhaustive clinical trials. The thrust of this grant lies in elevating the degree of automation in this process through the development of authenticated workflows and multiple case studies, with the ultimate goal of fostering broader acceptance and implementation of virtual bioequivalence practices within the pharmaceutical sector and among regulatory bodies.

Dermal PBPK modeling has emerged as a valuable tool for prognosticating drug absorption into the skin, especially pertinent in the realm of topical drug formulation development for virtual populations. The unique characteristic of topical products lies in their swift transformation post-application, attributed to the dynamics of their formulations. This grant seeks to support the creation and validation of a resilient dermal PBPK model, augmented by a specialized toolbox tailored for dermal formulations. This augmentation is projected to refine decision-making processes, mitigate risks, and optimize the efficiency and cost-effectiveness intrinsic to the development of generic drug products, all of which ultimately coalesce to serve the best interests of patients.

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