Dept. of Clinical Pharmacology and Pharmacoepidemiology

Analytical-Chemical Laboratory (ACL)

The ACL develops and validates analytical assays used in animal and human studies as well as in vitro studies to quantitatively determine drugs and drug candidates (small molecules, biologicals) as well as their metabolites and endocrine substances in biological samples. For this purpose, chromatographic and mass spectrometric methods (LC-MS/MS, UPLC-MS/MS, DESI- and MALDI-QToF) are used in combination with effective extraction procedures. The assays are validated in an ISO 9001:2015 certified environment according to ICH, EMA and FDA guidelines to meet all legal and regulatory requirements.

Head of Section

Dr. rer. nat. Jürgen Burhenne
Dr. rer. nat. Jürgen Burhenne

Our vision

Drug substances are efficiently and safely identified and quantified everywhere in the human and animal body ensure efficacy and safety of drug therapy.

Our mission

Using state-of-the-art methods, we determine exact drug concentrations in any biological material to support the success of drug therapies.

AREAS OF INTEREST

Our research interests include innovative analytical chemistry applications in the following clinical and pre-clinical application areas:

UPLC-MS/MS Assay Development

Drug quantification in samples of biological origin

Bioanalytical support of pharmacokinetic study projects in vitro und in vivo
Bioanalytics in clinical trials

GCP-compliant analytics in IITs and pivotal studies

Quality-optimized environment for analytics in clinical drug studies according to ICH, EMA and FDA
Mass spectrometric profiling

Analysis of drug distribution in target tissue

Determination of drug concentrations in compartments close to the site of action
Dried Blood Spots (DBS)

Low-invasive blood collection system for patients

DBS-based drug monitoring for neonates, children and adults at home
Innovative dosage forms

Improvement of the oral availability of therapeutic peptides

Optimization of carrier systems for targeted drug delivery
Therapeutic drug monitoring

TDM of antifungal therapy with the drug voriconazole

Quantification of plasma levels for monitoring and optimization of the therapy

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