Certara updates PBPK simulator to enable more realistic case modeling

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/seb_ra)
(Image: Getty/seb_ra)

Related tags: Certara, Simulation, PBPK, Pharmacokinetics, formulation

Certara launches version 18 of its physiologically-based pharmacokinetic (PBPK) Simcyp Simulator with new features including advanced food staggering and tumor models to optimize trial design and dose selection.

Certara’s Simcyp Simulator helps determine first-in-human (FIH) dose selection, design clinical studies, evaluate new drug formulations, and predict drug-drug interactions (DDIs) as well as pharmacokinetic (PK) outcomes in virtual patient populations.

Read: Certara outlines the role of quantitative systems pharmacology in FIH trial design, EMA responds

The new version of the Simcyp simulator features mechanistic absorption models, a new reverse translation tool (RTT) and an expanded compound library. It also includes new tumor models, an enhanced ADAM model to predict back-conversion of metabolites in the gut lumen, and expanded trial design capabilities to enable food and fluid staggering.

Masoud Jamei, PhD, senior vice president of research and development at Certara​ explained that it is important for drug developers, clinicians, and regulators to understand food and drug interactions, as food can affect how a patient’s body absorbs a drug product.

“After taking food, or even when we are thinking about food, various changes happen to our digestion system, for example, the gastric emptying becomes longer, blood flow to the gastrointestinal tract increases, bile salts secretion increase, etc.,”​ he added.

Such changes can affect how a drug is released from a formulation before it is dissolved, absorbed, and metabolized through the gut wall into the systemic circulation.

“The new V18 features take into account the relevant physiological changes and transitions between fasted and fed status and vice versa,”​ Masoud told us.

“As a result, investigating clinical studies and determining the optimal time for patients to consume food and fluids to either increase the drug bioavailability or avoid food-drug interactions are facilitated,” ​he added. “These also allow modeling more realistic cases where patients are taking drugs, meals, and fluids at the same time or at different occasions.”

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