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Simcyp workshop at Improving Solubility 2008 conference

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Start Date: 23 Jun 2008

End Date: 23 Jun 2008

Introduction to IVIVE for the prediction of the oral bioavailability of drugs from in vitro data - 23rd June 2008


This one day workshop precedes the International Quality and Productivity Center (IQPC) Improving Solubility 2008 Conference. The event is being held at the Thistle Marble Arch Hotel, London, UK.  

  

The focus of the workshop is the use of population-based IVIVE (in vitro - in vivo extrapolation) techniques for predicting the rate and extent of oral drug absorption and bioavailability, taking into account all the individual attributes of patients which may influence the process of drug absorption. Thus, the methodology inherently includes the simulation of inter-individual variability of bioavailability. This is based upon databases of population demography and physiological characteristics together with robust handling of covariates.

 

The workshop combines lectures on the principles of extrapolation with hands-on examples of applications using the Simcyp Population-based ADME Simulator (lap-tops will be provided – attendees do not need to be existing Simcyp Simulator users to benefit from the workshop). A clear distinction will be drawn between the prospective nature of IVIVE and the retrospective nature of methodologies such as in vitro - in vivo correlation (IVIVC).

The workshop will include coverage of the following main areas with emphasis on the solubility, dissolution and formulation-related aspects:

 

  • Introduction to IVIVE 
  • Brief overview of virtual populations - healthy, diseased, healthy volunteers (Phase I trials), paediatric 
  • Inter-individual variability relevant to bioavailability (gastric emptying, gut transit times, blood flow, pH etc.) 
  • Handling of in vitro solubility data (single point, kinetic, thermodynamic, pH-solubility profiles, precipitation) 
  • Use of diffusion layer models and particle size data to predict dissolution rate 
  • Handling of in vitro dissolution and controlled release profiles and how these propagate to in vivo plasma concentrations (with implications for bioequivalence studies) 
  • Handling of enteric coated formulations 
  • Handling of solubility measurements made in aqueous and bio relevant media 
  • Incorporation of regio-specific permeability, gut wall metabolism and P-gp efflux transport 
  • Handling of fed and fasted state responses

 

Please click here for further details on the Improving Solubility 2008 Conference and registration information for this workshop.


Consortium members and associates include: