Modelling and simulation in the development and regulatory review of medicines
EMA publishes guidance on the use of modelling and simulation software
The European Medicines Agency (EMA) has published a draft guideline on the use of new modelling and simulation software in the development of medicines.
The guidance focuses on the use of physiologically-based pharmacokinetic (PBPK) modelling.
Using specialised software, 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 clarifies how these models can support a marketing authorisation application.
It provides detailed advice on the data that should be included in a PBPK modelling report of an application dossier.
The document also emphasises the need for PBPK platforms to be ‘qualified’, or validated, for a specific use.
This can take place through EMA’s qualification of new methodologies for medicine development, which confirms that the use of a specific method is acceptable in the context of research and development.
The draft guideline clarifies which supportive data are needed to assess a PBPK platform.
Comments on the draft guideline should be sent to pkwpsecretariat@ema.europa.eu by 31 January 2017.
EMA will organise a workshop on 21 November 2016 to gather feedback on the draft guideline.
