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New version of the Simcyp Simulator released

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Date: 01 Apr 2008

Simcyp is pleased to announce the release of Version 8.0 of the Simcyp Population-based ADME Simulator. The new features and capabilities incorporated in this new release were determined in consultation with the leading pharmaceutical and biotech companies which make up the Simcyp Consortium.

The priorities for Version 8.0 were decided at the 7th Annual Simcyp Consortium meeting, held in late 2006. The top six ‘wish-list’ items have all been implemented. These include:

  • Expanded capabilities in the 'Advanced, Dissolution, Absorption and Metabolism' (ADAM module to accommodate different formulations
  • A mechanistic scaling approach for non-CYP metabolism (in gut, liver and kidney)
  • The availability of new population libraries (Cirrhosis, Renal Impairment, Obesity, Japanese and Healthy Volunteer [from Phase I trials])
  • In vitro - in vivo extrapolation of concentration-dependent CYP induction
  • An update of the current compound and population library values 
  • A more comprehensive Help File within the simulator and the production of a Simcyp user manual. 

In addition to the wish list items, Version 8.0 also incorporates many other new features, including:

  • Improved interface using HTML
  • An updated model to generate renal function based on serum creatinine
  • The addition of physiological boundaries for renal excretory clearance
  • The addition of a liver shunt feature to the PBPK models (necessary for Cirrhosis population)
  • Modification of the permeability calibrators

The Paediatric module of the Simulator, Simcyp Paediatric 2008’, has also been expanded and now includes many elements of the Version 8.0 physiologically-based pharmacokinetic (PBPK) model.  Prediction of paediatric PK from in vitro data has always been possible with Simcyp Paediatric; however, a ‘retrograde calculator’ has now been implemented which allows paediatric clearance to be predicted from adult in vivo values.

 


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