Physiologically-Based Pharmacokinetic Modelling in Virtual Human Populations and Preclinical Species.

Monday 16th October, 2017 – Simcyp (a Certara® company)

Certara® is the leading provider of decision support technologies and consulting services for optimizing drug development and improving both health, and safety outcomes. Simcyp (a Certara® company) develops and provides mechanistic, physiologically-based pharmacokinetic (PBPK) modelling services which enable the prediction of drug-drug interactions (DDIs) and simulations in special populations.

The Simcyp Simulator is the pharmaceutical industry’s most sophisticated PBPK platform. PBPK models describe the behaviour of drugs in different body tissues. The concentration of the drug in each tissue is determined by combining data on the system, drug, and trial design. The Simulator includes a unique set of genetic, physiological and epidemiological databases and can inform the optimization of first-in-human dosing, clinical study design, new drug formulation, and prediction of drug-drug interactions (DDIs) in virtual populations. This prediction of drug behaviour in virtual patient populations with different demographics, ethnicities, and diseases, instead of an ‘average’ human, allows high risk individuals to be identified.

In addition to modelling in humans, Simcyp Animal provides a PBPK modelling platform for commonly used pre-clinical species (rat, mouse, dog and monkey). Animal simulations can help identify key data requirements and refine the design of subsequent experiments. It can increase confidence in in vitro-in vivo extrapolation (IVIVE) before moving to human simulations and allows comparison of human and animal data without reliance on simple allometric scaling.

As well as research and development that underpins the continued development of the simulator, Simcyp scientists are active participants in multi-disciplinary projects (e.g. EUToxRisk, TransQST, eTRANSAFE) collaborating with industry, academia and regulators. This collaborative effort includes the provision of free software licences for teaching and research to qualifying academic centres. The impact of PBPK and mechanistic modelling with Simcyp is evidenced by the hundreds of peer-reviewed papers citing its use for drug development, toxicology and other key scientific areas.

We are keen to share our expertise and foster future collaborations that will further the development and impact of PBPK in the field of toxicology and beyond.

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