The overall intent of exploratory clinical studies is to provide information that allows assessing the clinical feasibility of new drug candidates early in the development process. Exploratory clinical trials therefore aim at early evaluation in humans of pharmacokinetic and and phamacodynamic profiles of novel compounds.

The doses applied in such studies are too low to be therapeutic or even to allow any meaningful PD assessment by conventional methods. Therefore, sensitive and specific (“surrogate”) PD markers – “biomarkers” – are required.

In an expert report, Dr. Eddy Bruyns, Dr. Matthias Baumann and Dr. Maikel Raghoebar of FOCUS have compiled information on the use of biomarkers in exploratory clinical studies and they provide a summary of the pertinent regulatory background.

They point out that PD biomarkers are feasible in many therapeutic areas, yet they are especially useful in the development of drugs for anti-inflammation and immuno-modulation. This is exemplified by several case studies.

To order a complimentary copy of the FOCUS expert report on the use of biomarkers in exploratory clinical studies enter your email address below and press the submit button:

A detailed complimentary copy of FOCUS’ expert report can be ordered by entering your email address below and pressing the submit button:

“FOCUS Immunology Laboratories Heidelberg” offer testing of biomarkers for immune cell functions tailored to the specific requirements of a given clinical trial.

For further information please contact Dr. Eddy Bruyns at eddy.bruyns@focus-cdd.com.