The biopharmaceutics performance of drug products can depend on multiple factors, including drug substance physicochemical properties, particle size distribution, patient physiology and dosage form composition. Even to the most experienced investigators, the interplay of these factors is not intuitive.

In silico modelling allows for the low cost, rapid identification of risk factors affecting drug absorption. Formulators can then develop risk mitigation strategies before clinical trials, allowing them to design clinical studies to understand, confirm and mitigate the predicted risks.

Topics covered

In this webinar, we will explore the high fidelity (or mechanistic) mathematical models which underpin the oral absorption and in vitro dissolution and precipitation simulations, in the context of case studies presented in previous gCOAS webinars. This will include:

  • Population balance tracking of particle size distribution
  • Detailed, mechanistic precipitation and dissolution models
  • Kinetic co-existence of multiple solid forms
  • Dynamic physiology fluid movement kinetics
  • Inter-digestive period simulation
  • Transit, secretions and physiological ion regulation

Presenter(s)

Edd Close
Edd Close, Senior Consultant, PSE

Edd Close is a Senior Consultant with PSE's Life Sciences business unit. He is the lead developer of gCOAS. Edd completed his EngD in Chemical and Biochemical Engineering at University College London.


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More Information

Duration

45 minutes plus Q&A

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Who should attend?

The webinar will be of use to formulation scientists interested in optimizing the clinical trial pathway through improved FIA formulations.