Simcyp PBPK Modeling and Simulation

Physiologically-based Pharmacokinetic (PBPK) Modeling: Getting Real Answers from Virtual Populations

A recent FDA draft guidance for industry, “Physiologically-based pharmacokinetic analyses—format and content” highlights the regulatory currency that PBPK now garners: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

The Simcyp Difference

Most of the top-40 pharmaceutical companies (including all of the top 10), along with the major regulatory bodies (FDA, EMA, PMDA) are members of the Simcyp® Consortium, which uses Certara’s Simcyp Simulator PBPK modeling and simulation platform to select the most appropriate drug doses, design optimal clinical trials, evaluate new drug formulations, and predict drug-drug interactions (DDIs) and PK outcomes in clinical populations. Simcyp Simulator models are used extensively to inform drug label claims.

Now all companies can leverage the Simcyp Simulator PBPK technology to inform critical drug development decisions via our Simcyp expert consulting team.

Certara’s Simcyp consultancy 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 with the client, Certara scientists can design a PBPK modeling and simulation strategy to answer a range of questions without having to resort to clinical study. Our bespoke, turnkey PBPK modeling and simulation (M&S) solution includes data review, project design, analysis, interpretation, and report writing.

Recent Examples of Simcyp Consultancy work include:

  • Designed a dosing regimen for a new oncology drug taking into account DDI interaction potential
  • Supported development of new and pediatric formulations
  • Evaluated the likely magnitude of interaction between caffeine and a new neurological drug
  • Developed a ‘virtual clinical PK package’ for a new chemical entity
  • Evaluated PK  changes in specific and ‘special’ disease populations
  • Supported dosing and administration guidelines for oncology, pulmonary, orphan, and CNS drugs
  • Investigated likely mechanisms behind clinically observed PK nonlinearities
  • Evaluated the likelihood and magnitude of DDIs prior to clinical investigation

Growing Impact of PBPK on Drug Labels

These new drugs leveraged Simcyp PBPK within the approved label, enriching the data on that label and oftentimes eliminating specific clinical studies.