The Simcyp Difference

Certara’s Simcyp PBPK 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 10 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 over 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 and 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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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An FDA draft guidance for industry, “Physiologically-based pharmacokinetic analyses—format and content” highlights the regulatory currency that PBPK now garners: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.”

Simcyp has been successfully accepted by the FDA and used in lieu of clinical trials delivering ~200 total label claims.

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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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Simcyp Consortium Members

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