Development and application of analytical methods for therapeutic drug monitoring

Therapeutic drug monitoring (TDM) subsumes the surveillance of medically prescribed drugs in patients. Toxicological analytical methods play a major role in TDM, as the determination of the substances as well as their quantification in biological samples allow conclusions concerning compliance or metabolism characteristics and, therefore, effectiveness of the given drug. Especially for substances that show a small therapeutic range or for newly launched drugs TDM is essential for a safe clinical appliance. The analysis of drug concentrations in different tissues (e.g. blood, plasma, urine, saliva) helps to find optimal application routes and to minimize unwelcome side effects. 

TDM is very important in opiate maintenance programs (OMP). In OMP, opiate-addicted patients receive methadone, buprenorphine or (in Austria) slow-release morphine for therapeutic purposes. The determination of drugs of abuse in urine is a premise to prove an opiate dependence and, after that, to control a co-consumption of illicit drugs. It has to be emphasized that the use of immunological methods alone is not sufficient. A differentiation of opiates is absolutely necessary in order to distinguish between prescribed morphine and illicit opiates such as heroine. In our lab analyses of urine samples of patients participating in OMP in Tyrol are regularly performed.

With our TDM lab we are involved in several scientific projects. To provide reliable quantitative data, validated assays employing state-of-the-art LC/MS or GC/MS technology are used. A number of assays are available for immediate application. For other targets an assay development service is provided. Please contact Herbert Oberacher for more information.

The following publications provide examples for the successful application of our analytical expertise to scientific studies:

  1. Bohn, J.-P.*, Willenbacher, W., Haas, G., Peschel, I., Oberacher, H., Steurer, M. Pomalidomide in Primary Intraocular Lymphoma. Leukemia & Lymphoma, 2018 accepted.
  2. Bohn, J.-P.*, Willenbacher, W., Peschel, I., Oberacher, H., Steurer, M. Second-generation Immunomodulatory Drugs in Leptomeningeal Myeloma. Leukemia & Lymphoma, 2018 accepted.
  3. Bonengel, S., Jelkmann, M., Abdulkarim, M., Gumbleton, M., Reinstadler, V., Oberacher, H., Prüfert, F., Bernkop-Schnürch, A.* Impact of Different Hydrophobic Ion Pairs of Octreotide on its Oral Bioavailability in Pigs. Journal of Controlled Release, 10 (2018), 21-29.
  4. Ortner, N. J., G. Bock, G., Dougalis, A., Kharitonova, M., Duda, M., J., Tuluc, P., Pomberger, T., Stefanova, N., Pitterl, F., Ciossek, T., Oberacher, H., Draheim, H. J., Liss, B., Striessnig, J.* Lower Affinity of Isradipine for L-type Ca2+ Channels during Substantia Nigra Dopamine Neuron-like Activity: Implications for Neuroprotection in Parkinson's Disease. The Journal of Neuroscience, 37 (2017), 6761-6777.
  5. Scharinger, B., Messner, B., Türkcan, A., Schuster, D., Vuorinen, A., Pitterl, F., Heinz, K., Arnhard, K., Laufer, G., Grimm, M., Stuppner, H., Oberacher, H., Eller, P., Ritsch, A., Bernhard, D.* Leoligin, the Major Lignan from Edelweiss, Inhibits 3-hydroxy-3-methyl-glutaryl-CoA Reductase and Reduces Cholesterol Levels in ApoE -/- Mice. Journal of Molecular and Cellular Cardiology, 99 (2016), 35-46.
  6. Erb, R., Leithner, K., Bernkop-Schnürch, A., Oberacher, H.* Phosphorothioate Oligonucleotide Quantification by Micro Liquid Chromatography - Mass Spectrometry. AAPS Journal, 14 (2012), 728-737.
  7. Beer, B., Schubert, B., Oberguggenberger, A., Meraner, V., Hubalek, M., Oberacher, H.* Development and Validation of a Liquid Chromatography-Tandem Mass Spectrometry Method for the Simultaneous Quantification of Tamoxifen, Anastrozole and Letrozole in Human Plasma and its Application to a Clinical Study. Analytical and Bioanalytical Chemistry, 398 (2010), 1791-1800.
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