Program

Physiologically-based Pharmacokinetic Modelling in Drug Development: A View from the Pharmaceutical Industry

[Speaker] Stefan Willmann:1
1:Clinical Pharmacometrics, Bayer AG, Wuppertal, Germany

Physiologically-based pharmacokinetic (PBPK) modelling has been increasingly used within the pharmaceutical industry and also gained acceptance in regulatory agencies over the past years. This technology makes use of prior physiological information that is relevant for the understanding and description of absorption, distribution, metabolization and elimination of the organism of interest as well as physico- and biochemical data of the drug candidate of interest.
Throughout the different stages of drug development, PBPK modelling can be applied in a descriptive manner for hypothesis testing, which physiological processes are most probably leading to observed animal or human PK data, or in a predictive manner to translate PK knowledge for example from animals to humans, from adults to children, or from healthy subjects to patients with certain pathophysiological conditions.
In this talk, recent application examples of PBPK modelling and simulation including potential benefits but also limitations of this technology will be discussed from the view point of the pharmaceutical industry.

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