Version 16 of Certara’s Simcyp Population-based Simulator, includes enhanced lung, pediatric, and GI transit models, as well as a new dermal absorption model, and a new report assistant.
Certara Senior Vice President, Ellen Leinfuss, told us drug developers and regulators are increasingly relying on mechanistic modeling, “specifically physiologically-based pharmacokinetic (PBPK) modeling, to provide valuable information relating to clinical trial design, the need for specific clinical trials, formulation design, dosing in special populations, and drug-drug interactions (DDIs).”
According to Leinfuss, the Simulator provides a better understanding of PK, DDI, food effect, the role of enzymes and/or transporters, and the effect of polymorphisms and ethnic differences.
“It enables us to study special populations, including pregnant women, renal- or hepatic-impaired, obese, geriatric or pediatric patients or those who have had bariatric surgery,” she said.
“Simcyp also provides a pediatric simulator that enables us to study how drugs will perform in children beginning with neonates. As organ development in children up to the age of two is non-linear, drug impact studies require this type of mechanistic modeling.”
Parameter estimation and sensitivity analysis capabilities have also been expanded, and biologics models and a biologics database for the Monkey Simulator are now available.