Toxicology

Inotiv provides general toxicology studies under internationally recognized regulatory guidelines for the safety evaluation of your small molecule, biotherapeutic drug candidate, medical device, or non-pharma product. Our experienced and proven scientific teams regularly contribute to successful Investigational New Drug application (IND), New Drug Application (NDA), and Biologic License Application (BLA) submissions. At Inotiv, you receive timely and reliable data that meet regulatory requirements and guidelines, including eCTD compliant reports and SEND compliant datasets. Our diverse capabilities enable us to offer flexible, targeted solutions to meet your needs at various phases of your program. We can provide a full safety assessment solution including customized study designs, dependable study conduct, sample analysis and data interpretation and reporting—or you can take advantage of our standalone services.

We Customize our Approach to Ensure You get the Insights Needed to Move Your Program Forward.

As part of Inotiv’s general toxicology program, we use rodent, non-rodent, NHP, canine, swine, and rabbit models offering:

• Acute single dose toxicity testing and repeat dose range-finding studies to help define and profile the core toxicities of your test article, providing data to establish acute exposure limits to the compound being tested. Studies are typically conducted in rodent and non-rodent models and range from 2-5 weeks in life.
• Subchronic and chronic toxicity studies using rodent and non-rodent models are developed to provide data that detects the physiological and pathological impact of a test article, which supports the strategic development of longer-term clinical trials. There are several study types involved with time ranges from 4 week to 9-month studies.
• Carcinogenicity rodent studies are designed to evaluate the tumorigenic potential of your drug candidate. We conduct carcinogenicity studies in full compliance with GLP regulations and offer the transgenic mouse model (rasH2) as a 6-month alternative to the full 2-year mouse carcinogenicity program. Learn more about our carcinogenicity services.

Your general toxicology programs need additional support, and we offer comprehensive integrated solutions or standalone services to provide you with the insights you deserve.

• Full histopathology support with our experienced staff of over 25+ ACVP board-certified pathologists who engage in consulting and expert interpretation for a broad spectrum of studies, tissues, species, and disease states. Learn more about how our histopathology services provide support for your projects.
• Additional pathology services include a comprehensive array of clinical pathology and biomarker services to support projects in animal models, discovery, and preclinical studies. Coupling traditional hematology, coagulation, clinical biochemistry, and urinalysis with targeted, next-generation biomarkers, our specialized pathology laboratory services are available to meet your clinical pathology and biomarker development needs. Learn more about how our clinical pathology services support you.

• Bioanalytical and pharmaceutical support with a team consisting of Principal Investigators and Scientists with an average of 15+ years of experience in regulated and non-regulated bioanalysis. We support small molecules, biotherapeutics, and biomarkers with method development, validation, and sample analysis. Learn more about our bioanalytical services and how we can support your project.

• Comprehensive drug metabolism and pharmacokinetic (DMPK) team with over 40 years’ experience of supporting pharmacokinetic and toxicokinetic (PK/TK) data analysis, PK/TK analytical modeling, dose analysis, drug-drug interaction potential, and bioequivalence/bioavailability analysis. Learn more about our DMPK services.
• Guidance to help plan your longer-term studies starts with optimizing study performance. We help you design your toxicology studies by selecting the appropriate in vivo models, dose concentrations, and routes of administration to enhance your outcomes. Learn more about how our consulting services can increase your probability of success.
• Research Models and Services provide you with a comprehensive selection of research animals needed to perform your safety assessment studies. We deliver timely solutions that ensure you have the resources needed to meet your scheduled milestones. To learn more about how our Research Models and Services can help you, click here.