The Simcyp Difference

Certara’s Simcyp Simulator is the industry-leading platform for physiologically-based pharmacokinetic (PBPK) modeling and simulation.

  • Includes a full PBPK model with extensive libraries on demographics, developmental physiology and the ontogeny of drug elimination pathways
  • Links in vitro data to in vivo absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic / pharmacodynamic (PK/PD) outcomes to explore clinical scenarios and support drug development decisions
  • Is used extensively to inform drug label claims.  Adopted by 11 global regulatory agencies including the US FDA, Japan’s PMDA, UK’s MHRA, the Simcyp Simulator has been used in lieu of clinical trials, delivering 200 total label claims to date.

In silico studies using PBPK models can test virtually unlimited “what if?” scenarios. The Simcyp consulting team offers PBPK modeling and simulation services on all aspects of drug absorption, distribution, metabolism and elimination (ADME) and PK/PD data analysis and interpretation.  Working alongside our partners, Certara scientists design PBPK modeling and simulation strategies to answer a range of questions without having to resort to clinical studies.

Benefits of physiologically-based pharmacokinetic modeling & simulation
  • Manage drug-drug interactions (DDI): Unmanageable DDIs have led to the withdrawal of numerous drugs.  Simcyp PBPK models allow investigation of mDDIs due to competitive enzyme inhibition, mechanism-based inhibition, enzyme induction, and polypharmacy.
  • Accelerate formulation development: The Simcyp Simulator’s Advanced Dissolution Absorption and Metabolism (ADAM) model can be used for mechanistic IVIVC.
  • Inform dosing for special populations:  The FDA requires that clinical studies be conducted in certain special populations (e.g., pregnant women, pediatrics). Ethnic groups and obese patients are worth considering, too.
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Bespoke PBPK modeling and simulation projects

Recent projects by Certara’s Simcyp consultancy:

  • Designed a dosing regimen for a new oncology drug taking into account DDI interaction potential
  • Supported development of new and pediatric formulations
  • Developed a ‘virtual clinical PK package’ for a new chemical entity
  • Evaluated PK changes in specific and ‘special’ disease populations
  • Evaluated the likelihood and magnitude of DDIs prior to clinical investigation
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From academic nicety to regulatory necessity

An FDA draft guidance for industry, “Physiologically-based pharmacokinetic analyses—format and content” highlights the regulatory currency that PBPK now garners:

“Throughout a drug’s life cycle, PBPK model predictions can be used to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, and to support dosing recommendations in product labeling.”

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Masoud Jamei, PhD Senior Vice President, Simcyp Research & Development

Masoud leads teams of scientists and programmers on the design, development and implementation of various aspects of systems pharmacology including in vitro-in vivo extrapolation techniques, physiologically-based PK/PD models, and the application of top-down PopPK data analysis to PBPK models in healthy volunteer and patient populations.

Karen Rowland Yeo, PhD Senior Vice President, Simcyp PBPK Consultancy Services

Since 2002, Karen has led projects relating to the extrapolation of in vitro data to predict in vivo pharmacokinetics in humans. This has included development and implementation of the models into the Simcyp Simulator.  Her specific research interests include physiologically based pharmacokinetic modeling and prediction of drug-drug interactions.

Hannah Jones, PhD Vice President, Head of PBPK Consulting Services

Hannah has over 17 years experience in global pharmaceutical organisations, possessing a particularly strong background in PBPK and PKPD modelling, She has over 50 publications in modelling and other DMPK related topics, responsible for influencing drug research and development programs through modelling and simulation.

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