Next Generation Risk Assessment (NGRA) is a procedure that integrates new approach methodologies (NAMs) to assure safety of a product without generating data from animal testing.
One of the major challenges in the application of NGRA to consumer products is how to extrapolate from the in vitro points of departure (PoDs) to the human exposure level associated with product use.
To bridge the gap, physiologically based kinetic (PBK) modelling is routinely used to predict systemic exposure (Cmax or AUC) from external exposures.
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