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in-silico Trials (computer modelling and simulation (:bulb:‘virtual’…
in-silico Trials (
computer modelling and simulation,
Related projects,
- The term ‘in silico clinical trials’ ISCT refers to: “The use of individualised computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention.”
- The aim is : ISCT models "... used over the entire product development and assessment process."
- Common practice so far, is separate models for specific phases.
- Little incorporation of physiology and individual variability
- Models and simulations that already exist not yet exploited
,
Avicenna Action Consortium : 35 countries, 22 from EU,
Clinical assessment common phases
- Phase I : small group - saftly.
- Phase II. : larger group - efficacy
- Phase III : much larger group - wider population
- Post-marketing studies : in ‘the real world’
)