OFM technology: Tissue specific quantification of lipophilic and high-molecular weight substances
Drug development is a complex, time consuming and cost intensive process. It requires the physiochemical determination and evaluation of a new substance. Furthermore, bioavailability, bioequivalence as well as toxicological aspects have to be examined.
To gain approval for any pharmaceutical drug the claimed effect at the intended target site has to be proven. Two parameters are used to describe the absorption and distribution as well as the biochemical and physiological effects of a drug – pharmacokinetics PK and pharmacodynamics PD.
The gold standard to determine PK and PD is plasma concentration, independent of how the drug is applied to the body and independent of where the drug should establish its effect. It is, however, questionable, whether plasma concentrations reflect concentrations at the target site, for example in the skin or the brain.
Open Flow Microperfusion - OFM
The FDA has indicated a need for tools to assess drugs and their effects directly at the target site, rather than indirectly via plasma concentrations.
To meet this need, we have developed a unique tool - the OFM technology.
A minimally invasive catheter is inserted into the target tissue. Its grid like structure enables direct contact with the interstitium. Interstitial fluid and biomarkers can be collected continuously and used for simultaneous analysis of multiple substances independent of their molecular size, lipophilicity and protein binding.
By using OFM, PK and PD of a drug can be measured continuously for more than 24 hours at the target site.
The OFM technology has proven to be a unique, safe and valuable tool for preclinical and clinical PK and PD studies. This tissue-specific method is minimally-invasive and continuously samples interstitial fluid in vivo. It provides a complete biochemical picture directly from the site of action. OFM can be used at an early stage in drug development and opens up new horizons in pre-clinical and clinical drug testing.
Our Services
JOANNEUM RESEARCH together with the Medical University of Graz is your competent and qualified partner for preclinical and clinical studies using the OFM technology. We perform PK and PD studies to investigate bioavailability and bioequivalence and to perform metabolomics in vivo and ex vivo.
We can assist you in
Preparing the study protocol
Submitting the ethical application
executing pre-clinical and clinical studies
validating the necessary bioanalytical procedures
and statistically analyzing the data
