Information on potential adverse effects and toxicity of the lead molecule is valuable already at the discovery stage of your project.
MADE toxicology service includes non-GLP in vivo dose range finding (DRF) and acute toxicity studies in mice and rats and GLP regulatory studies with partners.
The services have been designed to generate data that allow the elimination of unsuitable compounds and provide valuable input for designing regulatory toxicity studies.
Toxicological in vivo studies can be divided into non-GLP and GLP studies
Non-GLP studies are typically performed during drug discovery phase and they are used for evaluating the potential toxicity of a test item (as a screening test).
GLP studies are typically performed during drug development phase but in some cases it is cost effective to perform the GLP studies already in the discovery phase. GLP studies are performed for regulatory purposes (required before the clinical trials and/or marketing license) and all of them will be performed under OECD GLP guidelines.
Non-clinical safety studies can be started as soon as the test item (molecule) is stable and proper vehicle has been found. Preclinical studies are conducted in order to prove the safety and efficacy of a test item in in vivo level.
All in vitro studies are performed with the certified partners, with or without GLP status.