Dose-Exposure and PK/PD Studies

An important component of preclinical and translational science is to understand the relationship between dose and exposure and exposure and effect, which can assist in justifying initial clinical doses and how high to dose-escalate in the clinic. Many compounds reach a threshold at which increases in dose do not result in a proportional increase in exposure, and exposure can either be saturated or increased in a greater-than-dose proportional fashion. It is important to understand the dose-exposure relationship and, ideally, work with compounds in the linear range, where there is a proportional increase in exposure with an increase in dose. The evaluation of changes in preclinical biomarkers helps guide the dosing and evaluation of a therapeutic in the clinic. GD³ scientists can apply any of our capabilities (e.g., multiplex cytokine or hormone analysis, flow cytometry, PCR, complete blood counts, immunohistopathology) to your program needs or can work with you in the development of new biomarkers.

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