Company: NOTV
Filing Date: 2025-12-05
Form Type: 10-K
Source: 0001628280-25-055483
Chunk: 83

Company: Inotiv, Inc.
Filing Date: 2025-12-05
Form: 10-K
Item: Item 1
Chunk 83
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 of the largest global pharmaceutical companies, whose scientists are engaged in analytical chemistry, drug safety evaluation, drug metabolism studies, pharmacokinetics, clinical trials, and basic research.  

Through our RMS segment, we offer access to a wide range of purpose-bred animal research models for basic research and drug discovery and development, specialized models for specific diseases and therapeutic areas, and diet, bedding and enrichment products, all supported by our deep animal husbandry expertise. We have the ability to run selected nonclinical studies directly on-site at closely located research model facilities and provide access to innovative genetically engineered models and services solutions. Our principal clients include biopharmaceutical companies, CROs, and academic and government organizations. 

Discovery and Safety Assessment

The DSA segment is comprised of two principal areas of services: Discovery and Translational Sciences and Safety Assessment. 

Discovery and Translational Sciences

•Bioanalytical Method Development: Analytical methods are developed and validated in a manner designed to ensure that data generated are accurate, precise, reproducible and reliable and are used consistently throughout the drug development process and in later product support. This includes early-stage and fit-for-purpose discovery methods that are generated to provide information on drug concentration in biological matrices, and can be used to quantify certain safety or efficacy biomarkers to aid compound selection.

•In Vivo Pharmacology: We provide preclinical in vivo efficacy services. In vivo pharmacology is strengthened by the combination of our genetically-modified rodent production capability which provides animals with specific genetic modifications necessary for evaluation of new molecular targets and by our ability to use advanced proteomic technologies to characterize the pharmacological target and the model's responses to intervention.

•Exploratory Pharmacokinetics and Toxicology: We evaluate the initial pharmacokinetics of drug candidates to determine oral bioavailability, dose proportionality of exposure, gender differences, and time-dependent changes in exposure in our laboratories. In addition we provide initial safety evaluation of drug candidates through the conduct of single and repeated dose exploratory toxicology studies designed to identify tolerability and target organ toxicity and to provide guidance for dosing of more extensive pivotal studies which are intended to support human clinical trials. 

Safety Assessment

•Non-clinical Toxicology and Pathology Services: We provide safety testing in studies ranging from acute safety evaluation of drugs and medical devices to chronic, multi-year oncogenicity studies, and safety evaluation focused on developmental and reproductive toxicology. We also provide services in toxicologic pathology and evaluation of tissues from animal efficacy models, surgical modeling and focused evaluation of biomedical