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Clinical pharmacology encompasses all aspects of the relationship between drugs and humans. The aim is to ensure the safe, effective, and economical use of drugs based on reliable scientific findings, both in defined patient groups and specifically in individual patients. In this context, Clinical Pharmacology contributes to the early clinical development of drugs and the optimal use of available drug therapies.

To turn a chemical substance into an approved drug for the treatment of patients, extensive trials have to be carried out.
The final step in this process is the investigation of the tolerability, effect, and fate of the drug substance in humans. This is done within the framework of medically supervised clinical trials. Similar studies are also required to optimize therapy with drugs that have already been approved.

Clinical trials are performed on different subjects: healthy volunteers, patients with renal dysfunction, patients with hepatic dysfunction, or patients with the disease to be treated for that drug.
 
At the Center for Pharmacology, we conduct clinical trials, sometimes in collaboration with other departments at the University Hospital.

We are currently seeking subjects for the following studies:

Healthy volunteers are needed for the alcohol study

Healthy Volunteers needed for a Research Study on Alcohol

Pharmacokinetic biomarkers

The kinetics of drugs (pharmacokinetics) and other xenobiotics are determined by the activity of underlying pharmacokinetic processes (including glomerular filtration and turnover by xenobiotic-metabolizing enzymes and transporters). Based on in vitro data, the prediction of the activities of these processes in humans is limited. Therefore, we develop and validate, among others using clinical studies, methods to selectively measure such activities in individual subjects or patients by means of endogenous or exogenous marker substances. Pharmacokinetic biomarkers also enable the quantification of corresponding influencing factors (e.g., in drug interactions) and contribute to an individually optimized dosage of drugs.

Clinical studies in healthy volunteers

Clinical studies in healthy volunteers are indispensable for determining the safety and tolerability, pharmacokinetics, and effects of drugs in humans. We conduct clinical studies on our volunteer ward (12 beds) by the German Medicines Act (AMG) and outside the regulations of the AMG. Quality is ensured by adherence to the applicable GCP (good clinical practice) guidelines and by following our standard operating procedures (SOPs). We can carry out all tasks independently, from conception to preparation of the necessary documents, submission to ethics committees and authorities, operational implementation, evaluation, and reporting. Still, we are also happy to work with cooperation partners.

Clinical studies on patients

In cooperation with the clinics of the University Hospital as well as with other cooperation partners, we participate in clinical studies in patients in which the pharmacokinetic question is to be tested. The type of cooperation ranges from limited collaboration about a specific task to leading research, depending on the research question and the preferences of the cooperation partners.

Population pharmacokinetic/pharmacodynamic modeling and simulation

Using this "top-down" method (software: NONMEM, Monolix, among others), we determine the pharmacokinetic and pharmacodynamic properties of drugs and other xenobiotics from experimental data of clinical studies and simultaneously record the variability of drug concentrations in the population under investigation. The contribution of influencing factors such as the activity of underlying pharmacokinetic processes (see section "Pharmacokinetic Biomarkers") or anthropometric data to the overall variability can be tested and quantified.

Physiology-based pharmacokinetic (PBPK) modeling of drugs

With PBPK modeling of drugs (software: e.g., PK-SIM), we try to describe and predict concentration-time courses of drugs in organs and tissues of an organism based on physicochemical properties of a substance and the activity of pharmacokinetic processes relevant for this substance ("bottom-up" method). If the predictions of such models are in good agreement with experimentally collected data, they can also make predictions and provide dose recommendations for unstudied populations (e.g., the elderly) without the need to conduct new clinical studies for each individual question.

For further information, please get in touch with Univ.-Prof. Dr. Uwe Fuhr.