Modelling and simulation in the development and regulatory review of medicines

News 29/07/2016

Comments on new guidance invited until 31 January 2017

The European Medicines Agency (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.

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 novel methodologies for medicine development, that 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, by 31 January 2017, using the form provided.

EMA will organise a workshop on 21 November 2016 to gather stakeholders' feedback on the draft guideline. The workshop is expected to bring together experts from academia, industry and regulatory bodies, as well as PKPB software developers. Comments will be taken into account in the finalisation of the guideline.

The workshop will be broadcast live. A call to register will be published on the EMA website in due course.

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