Non-regulatory preclinical toxicology
Non-regulatory preclinical toxicology studies in rodents involve exploring and assessing the potential toxic effects of substances or drugs in order to generate exploratory data and gain a better understanding of toxicity mechanisms before moving on to regulatory studies.
These studies allow to define toxicity profile of your drug candidate, by determining a substance’s maximum tolerated dose (MTD) and no observed adverse effect level (NOAEL), and the appropriate dose range (DRF: Dose Range Finding) to achieve therapeutic effects while minimising toxicity. It explore therapeutic dosing ranges to optimize efficacy while reducing risks, evaluating both immediate effects through single-dose acute studies and prolonged impacts via repeated-dose subacute/chronic investigations. Comprehensive assessments, including behavioral and clinical observations, bloodwork, biochemical markers, tissue examinations, and metabolic profiling, generate foundational insights into safety profiles and biological mechanisms. At the end of the study, necropsy of rodents and organ management will be performed in accordance with the recommendations of the RITA Group, with microscopic analysis of the tissues harvested, carried out by specialist veterinary pathologists. The overall of these findings will guide your decisions about advancing of your drug candidates to regulatory evaluations.
Bone toxicology studies
Bone toxicology studies in rodents aim to assess the potentially toxic effects of drug candidates, nutraceuticals or biomaterials, more specifically on bone tissue.
This type of study makes it possible to investigate the potential effects of the compounds to be tested on bone development, bone density or bone repair, and to identify the mechanisms of action involved.
The particularities of bone toxicology studies are the following :
- The macroscopic and microscopic examinations, with bone and bone tissue harvested at autopsy for in-depth histopathology analysis, with microscopic examinations carried out on bone tissue to detect structural or cellular abnormalities using specific scoring systems, following standardised recommendations such as those of OARSI.
- Biochemical and functional analyses, with the measurement of specific biomarkers in blood or urine to assess bone metabolism.
- Biomechanical tests to detect abnormalities linked to bone toxicity.
- Imaging, with µCT analysis to measure bone mineral density and assess the effects on bone microarchitecture.