“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
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.
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Certara Contact:
Sheila.rocchio@certara.com
Media Contact:
ariane.lovell@finnpartners.com
Investor Relations Contact:
ir@certara.com
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