EMA Issues Draft Guidance on Modeling and Simulation

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-03-2016 08:46


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 specialized 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 pediatric and first-in-human trials.

The draft guideline clarifies how these models can support decision-making in the context of a marketing authorization application. It provides detailed advice on the data that should be included in a PBPK modelling report of an application dossier. The document also emphasizes the need for PBPK platforms to be "qualified," or validated, for a specific use. This can take place through the 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 are due by January 32, 2017. The EMA will organize a workshop on November 21, 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 finalization of the guideline.

Source: European Medicines Agency


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