Pharmacokinetics (PK) / Pharmacodynamics (PD) Assessments

In addition to PK assays, the analysis of pharmacodynamic (PD) markers is a central aspect to study the biochemical and biological effects of drugs and the mechanisms of their actions, including the correlation of their actions and effects with their chemical structure.

Pharmacodynamic (PD) markers monitor biological effects used in decision making in early drug development. PD markers are used in pre-clinical and clinical studies for establishing doses and dosing regimen for future studies.

Often PD markers are generic but the assays have to be validated for their intended purpose. Some PD markers are regulated upon treatment, e.g. neopterin and 2′-5′-OAS upon interferon treatment, but often these markers are also regulated by non-drug induced events and have a limited values. The search for specific PD markers is challenging and in the focus of many research groups.

The analytical spectrum for the detection of PD markers is broad and comprises molecular techniques such as quantitative real-time RT-PCR and immunological techniques such as ELISA, ECL, CLIA, RIA and others.