The purpose of our non-clinical animal studies is to determine safety margins with respect to the efficacy of the compound and acceptable adverse effects for the drug candidates being studied. The studies are designed to characterize potential toxicity and to determine the no-observed-adverse-effect-level (NOAEL). We work with a focus on 3R.
In our GLP-compliant laboratory with biosafety level (BSL) 2, we conduct non-clinical safety assessment studies in areas such as pharmaceuticals (small molecules, biologics, and vaccines), chemicals, medical devices and food additives. Our award-winning focus on the 3R principles, with well-managed animals in a highly enriched environment, has been internationally recognised and ensures the delivery of highest quality scientific results in harmony with an exceptional standard of animal welfare. Irrespective of the aim (regulatory or non-regulatory), we conduct all our studies to the highest possible standards. We work to minimise stress in the animals to get the best possible results.
At RISE, we carry out studies in rodents, but can broker, coordinate and monitor outsourced studies in other animal species (e.g., dogs and pigs) conducted in external laboratories. With our knowledge and experience we can help you to tailor your studies to specific requirements, and our staff work in a highly integrated manner with other capabilities, such as bioanalysis, minimizing lead times to critical path data. This integration ensures an increased efficiency in data collection, speeding the delivery of a study report. Should problems or challenges arise during the course of the study, our flexibility and experience in problem-solving will provide quick and effective solutions.
Our services provide all necessary data from detailed in-life observations and clinical chemical, haematological, histopathological, pathological, and kinetic analyses, directly utilizing blood, plasma, serum, urine and bronchoaleveolar lavage (BAL) from the in-life phase.
Our animal laboratorians are a team of more than 10 people with extensive experience in animal research methodology that cover the most usual administration routes and blood sampling sources.
If you require studies in species other than rodents, we can either assist you with outsourcing new studies or mediate in already outsourced studies in contract labs and help you coordinate and monitor the experiments. We can also provide full project responsibility for the entire study if desired. Our animal laboratory can also offer housing and care for rodents should you want to conduct your own animal studies at our facility.
The principles for determining the safety margins in animal toxicity studies are the same regardless of whether they are drug candidates or industrial chemicals. In the former case, these are determined with respect to the efficacy of the compound and in the latter towards an acceptable exposure level, and in both cases are designed to characterise the potential toxicity and to determine the NOAEL.