Dept. of Clinical… Reference Lab…

 

The Heidelberg Reference Lab for Pulmonary Arterial Hypertension (PAH) is dedicated to the quantification of drug concentrations of targeted therapies in samples of PAH patients with the ultimate goal to elucidate the concentration-effect relationship of these drugs. As a strong partner for clinical, scientific, and industrial PAH researchers, we make these methods available for quantification of drug exposure in clinical drug trials and animal experiments and also offer this expertise to clinics and PAH centres for diagnostic and monitoring purposes.

 

Currently ambrisentan, bosentan, sildenafil, and tadalafil are quantified and further assays are under development. All drug quantifications are performed with state-of-the-art tandem mass spectrometry equipment (LC/MS/MS and UPLC/MS/MS) including Waters and Thermo Finnigan instruments and validated blood extraction procedures. The PAH Reference Lab is certified according to ISO 9001:2008 and all methods are validated according to FDA’s Guidance for Industry: Bioanalytical Method Validation (Mai 2001) and EMA’s Guideline on Bioanalytical Method Validation (February 2012).

 

Before sending patient blood samples please download and fill in our analysis request form, which also describes the appropriate blood handling and shipment procedure.

In case of any questions, please do not hesitate to contact us.

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