Programs focus on use of physiologically-based pharmacokinetic (PBPK) modeling for demonstrating virtual bioequivalence and predicting drug absorption of topical formulations
PRINCETON, N.J.— 2023 年 8 月 29 日– 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 biosimulationfor improving patient health.”
虚拟生物等效性
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.
关于Certara
Certara 利用生物模拟软件、技术和服务加速药物研发，从而改变传统的药物研发方式。其客户包括超 2,300 家生物制药公司、学术机构和来自 70 个国家的监管机构。了解更多信息，请访问 www.certara.com.cn。
Certara 联系人：
Sheila Rocchio
sheila.rocchio@certara.com
媒体联系人：
Ariane Lovell
Finn Partners
ariane.lovell@finnpartners.com
Investor Relations Contact:
David Deuchler
Gilmartin Group
ir@certara.com
