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Development of good modelling practice for phsiologically based pharmacokinetic models for use in risk assessment: The first steps
Citation:
Loizou, G., M. Spendiff, H. A. BARTON, J. Bessems, F. Bois, M. Bouvier d Yvoire, H. Buist, H. Clewell III, B. Meek, G. Goerlitz, AND W. Schmitt. Development of good modelling practice for phsiologically based pharmacokinetic models for use in risk assessment: The first steps. REGULATORY TOXICOLOGY AND PHARMACOLOGY. Elsevier Science Ltd, New York, NY, 50(3):400-411, (2008).
Impact/Purpose:
Clear descriptions of good practices for 1) model development (i.e., research and analysis activities), 2) model characterization (i.e., methods to describe how consistent the model is with biology and strengths and limitations of available model and data, such as sensitivity analyses), 3) model documentation, and 4) model evaluation (i.e., independent review), will assist risk assessors, in their decisions of whether and how to use the models, but also model developers to understand expectations for various purposes (e.g., research versus application in risk assessment).
Description:
The increasing use of tissue dosimetry estimated using pharmacokinetic models in chemical risk assessments in multiple countries necessitates the need to develop internationally recognized good modelling practices. These practices would facilitate sharing of models and model evaluations and consistent applications in risk assessments.
