ABSTRACT
Translational biomarker pharmacokinetic/pharmacodynamic (PK/PD) modeling utilizes preclinical in vitro and in vivo data and employs mathematical and statistical models to describe and understand them. The PK/PD models developed can then be used to refine preclinical experiments and extrapolate findings to the clinical setting. The frequent use of human tumor cells lines in xenograft models perhaps encourages the use of PK/PD and biomarkers approaches. Despite the insight the PK/PD understanding bring, the latest metrics show that attrition remains an issue for cancer as for other indications. The majority of the preclinical translational biomarker PK/PD in neurology has been carried out for Alzheimer’s disease, with, for example, extensive enquiries made into amyloid-beta species using direct binding or production inhibitors. Translating preclinical biomarker PK/PD for anti-infectives to humans has been carried out with arguably some success, at least in specific cases. Translational PK/PD of bacterial infections has been often carried out using mouse models.
