The new draft EMA Guidance on PBPK – The qualification of the intended use concept
Anna Nordmark (1)
(1) Medical Products Agency, Uppsala, Sweden
Objectives: Aspect regarding the Draft EMA PBPK guideline will be presented.
Overview/Description of presentation: The use of physiologically based pharmacokinetic (PBPK) modelling has been increasingly seen in applications submitted to European agencies as well as requested by regulatory agencies in Europe during assessment of marketing authorisations. At present the intended use is mainly PBPK simulations for drug-drug interaction scenarios. Available EMA guidance covers the principles and the general approach to the use of PBPK analysis. The draft EMA Guideline on the Qualification and reporting of PBPK Modelling and Simulation was released for public consultation in July 2016 [1]. During the consultation period a workshop with interested parties was held. Some highlights from this workshop will be presented in this presentation as well aspect from the draft Guideline regarding Qualification of the intended use illustrated with some case examples. Further, some aspects around reporting will as well be described.
References:
[1] Draft Guideline: Qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/clinical_pharmacology_pharmacokinetics/general_content_001729.jsp&mid=WC0b01ac0580032ec5