Certara Simcyp™ Group Awarded Two New Grants from US FDA
29 Agosto 2023 - 7:15AM
Certara (Nasdaq: CERT), a global leader in biosimulation, today
announced that the Simcyp group has been awarded two new grants
from the U.S. Food and Drug Administration (FDA) to expand its
predictive models for assessing drug virtual bioequivalence (VBE)
and to create a formulation toolbox for topically applied drugs.
These capabilities will help enable safer, faster and more
cost-effective product development of both complex generics and
novel drugs.
“We are proud to collaborate with the FDA in developing
innovative model-informed approaches for accelerating drug
development of complex generic and innovator drugs,” said Rob
Aspbury, President of Certara, Scientific Software. “The Simcyp
Simulator has already proved its ability to replace clinical
studies in both VBE and dermal absorption. These new grants will
further demonstrate the predictive performance and reliability of
biosimulation for improving patient health.”
Virtual Bioequivalence Bioequivalence (BE)
studies, which are used to show that the rate and extent of
absorption of the investigational product are not significantly
different from those of the comparable reference drug product, can
be costly and time-consuming. VBE trial simulations, using
mechanistic PBPK modeling, address this challenge by simulating
realistic virtual cohorts of patients to reduce and or replace
clinical trials. This grant will support increased automation of
this process by developing verified workflows and multiple case
studies to increase wider adoption of VBE by industry and
regulators.
Dermal Formulation Modeling Dermal PBPK
modeling has been applied to the development of topical
formulations by predicting drug absorption into the skin in virtual
populations. Topical products undergo changes immediately upon
application due to formulation metamorphosis, which may alter the
critical characteristics of the formulations. This grant will
support the development and verification of a reliable and robust
dermal PBPK model enhanced with the specialized dermal formulation
toolbox to aid decision-making and result in lower risk, more
efficient and cost-effective development of generic drug products
providing benefits to patients.
Learn more about how Certara supports virtual bioequivalence
here.
About Certara Certara accelerates medicines
using biosimulation software, technology and services to transform
traditional drug discovery and development. Its clients include
more than 2,300 biopharmaceutical companies, academic institutions,
and regulatory agencies across 70 countries. Learn more at
Certara.com.
Certara Contact: Sheila
RocchioSheila.rocchio@certara.com
Media Contact:Ariane LovellFinn
Partnersariane.lovell@finnpartners.com
Investor Relations Contact:David
DeuchlerGilmartin Groupir@certara.com
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