Posted by Michael Wonder on 31 Jul 2016
Modelling and simulation in the development and regulatory review of medicines
29 July 2016 - Comments on new guidance invited until 31 January 2017.
The EMA has published a draft guideline to support and guide the use of innovative modelling and simulation approaches that are currently being used during the development of medicines.
The draft guideline focuses on the use of physiologically-based pharmacokinetic (PBPK) modelling. Using specialised software platforms, these models aim to simulate the concentration of a medicine in the body over time. They are increasingly used by medicine developers for various purposes such as predicting the interaction between medicines in the body or helping to define the initial dose of a medicine in paediatric and first-in-human trials.
The draft guideline published today clarifies how these models can support decision-making in the context of a marketing authorisation application. It provides detailed advice on the data that should be included in a PBPK modelling report of an application dossier.
