A BIOLAURUS SPECIALTY
Safety and Toxicology Studies
Many drugs have off target toxicity at lower concentrations or with chronic exposures that are undetected in standard preclinical GLP toxicity studies. Many cancer chemotherapeutics for example have either renal, hepatic, cardiac, hemostasis, or CNS toxicity. Many times safety pharmacology and toxicity questions arise during clinical Phase II and Phase III trials.
We called upon to devise and carry out preclinical research to quickly discern the degree of safety/toxicity, as well as mechanism of action (MOA) which might suggest the means to mitigate or remove the core safety/toxicity issue. Where no existing imaging assay exists we can usually create it.
This is one of the things we do best
Functional organ toxicity at early stages can only be determined in-vivo by imaging and is largely beyond the capabilities of gold standard histopathology.
The power of functional imaging is the detection of changes in cellular and tissue function which occur before overt histologic changes. Functional imaging allows for examination of organ function in live animals and longitudinally. This approach does not replace histopathology, but compliments it. At the core of functional imaging (whether fPET, fSPECT, fCT, fMRI, or fUS) is the identification of relevant functional markers. These makers may track normal function such as MAG3 which is used to measure renal function, or identify markers of cell change such as annexin-V which is a marker of apoptosis. Manu functional markers of renal, hepatic, cardiac, hemostasis, or CNS toxicity are in wide use in the clinic; BioLaurus is bringing them to the preclinical research space.
BioLaurus can work with your team to select the markers and modalities best suited to your research needs. Many of the current repertoire of functional markers are translational having been first developed in the clinic but there are new markers under development. BioLaurus has extensive experience in assay development and can work with you to develop new imaging markers and assays.