Computer modelling and simulation is a method that can be used to predict and/or confirm drug and formulation behaviour in vivo and facilitates the understanding of the exposure/response relationship. Seda provide PK modelling services for the integration of data to mitigate the risks of drug properties impacting drug absorption and uncovers the relationship between dose, exposure and biological effect.
Modelling and simulation is used throughout development to guide and support longer term development strategy and clinical investment decisions. It puts emerging clinical data into context with preclinical and clinical data already available. Modelling and simulation can therefore build confidence in the development of your chosen compound/formulation leading to reduced clinical testing and costs.
PBPK modelling is the combination of a set of known physiological parameters, in vitro ADME and invivo PK data, along with certain in silico values to create a dynamic model that describes the PK of a drug. This model can be used to understand and simulate PK in pre-clinical species and for first-in-human PK predictions. If PBPK models can be successfully be developed they have the potential to reduce the need for animal and human testing.