Safety assessment, efficacy, and mode-of-action studies to support regulatory requirements, pre-clinical safety, and investigative toxicology.
Inotiv’s in vivo toxicology team conducts pre-clinical safety and efficacy studies to meet regulatory requirements and non-GLP investigative studies supporting discovery research.
Inotiv routinely provides regulatory toxicology testing in rodent species to comply with OECD, FDA, and EPA test guidelines and meet US FDA, US EPA, ICH, and worldwide regulatory agency requirements.
We utilize the latest genomic profiling techniques to investigate mode-of-action and risk assessments, and regularly integrate services with other Inotiv teams to support in vivo toxicogenomic studies.
We have extensive experience in designing, conducting, evaluating, and interpreting study results that cover various endpoint analyses (toxicology, pathology, biochemical, and molecular), and can draw on the full range of Inotiv services from genetic and in vitro toxicology to pathology and histology.
We efficiently get you the data you need, in the format you require (including eCTD compliant reports and SEND compliant datasets), so you can make timely and fully informed decisions regarding mode-of-action and potential adverse effects and relevance to humans.
In addition to traditional regulatory toxicology studies, Inotiv also designs in vivo toxicogenomic studies that include dose-response and bioinformatics, to determine differentially expressed genes and genomic response pathways, and derive benchmark dose used in risk assessments.