EMA has published a draft guideline to support and guide the use of innovative modeling 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") modeling. 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. Comments on the draft guideline should be sent to pkwpsecretariat@ema.europa.eu by January 31, 2017.
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