Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator is being used to verify and expand biosimulation models for assessing virtual bioequivalence (VBE) of complex generic drugs
PRINCETON, N.J.— 2023年2月7日. Certara (Nasdaq: CERT), a global leader in biosimulation, today announced the Company has been awarded work with the University of Florida and the University of Rhode Island, derived from two grants from the U.S. Food and Drug Administration (FDA). The grants are awarded to the universities to verify and expand biosimulation models for assessing virtual bioequivalence (VBE) to help expedite safer and more cost-effective generic drug development.
A subset of generic drugs to be investigated in these grants includes dermal drugs. The dermal drug delivery market is growing. According to Vision Research Reports, the global topical drugs market was valued at USD 97.51 billion in 2021, and it is predicted to surpass around USD 217.9 billion by 2030 with a CAGR of 9.35% from 2022 to 2030.
Grant #1 – with University of Florida – 2 year grant
Today, VBE assessments are reviewed by the FDA on a case-by-case basis. The work on this grant is intended to achieve a more universal approach, leveraging PBPK, to better reflect conditions at the site of action within the GI tract for orally dosed drug products.
In collaboration with the University of Florida (UoF) we will develop a model-integrated evidence-based framework leveraging both available clinical data (i.e., systemic and intraluminal exposure) for strategically selected model drug products and novel in vitro data generated by UoF using in vitro systems designed to bridge current knowledge gaps to support demonstration of local and systemic BE for locally-acting GI drug products using physiologically-based IVIVCs.
This grant demonstrates the FDA’s ongoing commitment to identify alternative approaches to clinical bioequivalence studies for complex generics”, said David B. Turner, Ph.D., Principal Investigator, and Senior Principal Scientist, Modeling and Simulation at Certara. “PBPK modelling is beneficial for compounds that are not highly permeable (many GI locally acting drugs), where absorption is complex, and where local concentrations of drug in the gut are not readily quantifiable experimentally, as this impacts the ability to achieve bioequivalence in drug formulation.”
Funding for this collaboration is made possible by the Food and Drug Administration through contract: Unique Federal Award Identification Number (FAIN): 1U01FD007662-01
Grant #2 – with University of Rhode Island – 4 year grant
The grant is titled “In Vitro Based Approaches to Evaluate the Bioequivalence of Locally-Acting Rectal and Vaginal Semi-Solid Drug Products”. Certara will develop and verify physiologically based pharmacokinetic (PBPK) models for the drug products of interest using the Simcyp software’s modules for rectal, intravaginal, and in vitro permeation testing (IVPT) absorption. These PBPK models will integrate the generated drug product characterization and IVPT data into the existing rectal, intravaginal and IVPT model structures. With these, the Certara will explore the potential for establishing in vitro – in vivo correlations and, ultimately, in vitro / in silico bioequivalence assessment methodologies for rectal and vaginal drug products.
To learn more about Certara’s virtual bioequivalence technology, visit https://www.certara.com/services/virtual-bioequivalence/
Funding for this collaboration is made possible by the Food and Drug Administration through contract: Unique Federal Award Identification Number (FAIN) U01FD007656.
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