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Certara's scientific consultants support strategic drug development decisions and submission-ready analyses.

Simcyp Consultancy Services

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PBPK Modeling and Simulation

Building Prospective Clinical Knowledge From Your In Vitro ADME Data 

Physiologically-Based Pharmacokinetic (PBPK) models describe and predict the handling of drugs by the body in a realistic way based on demography, physiology, biochemistry and genetics. We integrate this information with in-vitro drug absorption, metabolism and transport data to simulate and predict in-vivo pharmacokinetics in virtual patient populations. Such ‘population-based’ PBPK modeling is increasingly being used in regulatory review to facilitate decisions on the necessity for specific clinical studies, to inform study design and guide appropriate labeling language.

Simcyp is the leader in mechanistic pharmacokinetics with an international reputation in vitro-in vivo extrapolation of drug absorption, distribution, metabolism and elimination (ADME) data. In addition to licensing the Simcyp Simulator we offer consultancy services on all aspects of drug ADME and PK/PD data analysis and interpretation.

Using your data, Simcyp’s scientists can provide advice on the design of your ADME experiments and deliver independent analysis, interpretation and reports. This service is ideally suited to those clients who do not have the resource, time or need to use our simulation technology directly.


Benefits of PBPK Modeling and Simulation With Simcyp

Here are just a few examples of where Simcyp Consultancy has helped clients:

  • Predicting first-time-in-man dose
  • Avoiding unnecessary drug-drug interaction (DDI) studies
  • Prediction of paediatric exposure
  • Candidate selection
  • Formulation development
  • Development of patient population
  • Prediction of impact of hepatic disease