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Dept. of Clinical…

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.



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 DevelopmentDrug quantification in samples of biological originBioanalytical support of pharmacokinetic study projects in vitro und in vivo 

Bioanalytics in clinical trialsGCP-compliant analytics in IITs and pivotal studiesQuality-optimized environment for analytics in clinical drug studies according to ICH, EMA and FDA 

Dried Blood Spots (DBS)Low-invasive blood collection system for patientsDBS-based drug monitoring for neonates, children and adults at home 

Mass spectrometric profilingAnalysis of drug distribution in target tissueDetermination of drug concentrations in compartments close to the site of action 

Innovative dosage formsImprovement of the oral availability of therapeutic peptidesOptimization of carrier systems for targeted drug delivery 

Therapeutic Drug MonitoringTDM of antifungal therapy with the drug voriconazoleQuantification of plasma levels for monitoring and optimization of the therapy 

Therapeutic Drug MonitoringTDM for the new drugs in anticoagulation therapyCorrectly adjusted blood thinning protects against stroke, hemorrhage, and heart attack 

Therapeutic Drug MonitoringTDM for the therapy of pulmonary arterial hypertensionThe right combination and concentration of PAH medication prolongs life 



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