WEST LAFAYETTE, Ind., May 04, 2023 (GLOBE NEWSWIRE) -- Inotiv, Inc. (Nasdaq: NOTV), a leading contract research organization specializing in nonclinical and analytical drug discovery and development services, and research models and related products and services, announced today the expansion of the Company’s safety pharmacology offering with the validation and verification of a cardiopulmonary telemetry study model in cynomolgus macaques. Offered through Inotiv’s Discovery and Safety Assessment business, telemetry allows for the continuous observation of ECG, respiratory rate and volume, blood pressure and other cardiovascular parameters during preclinical safety studies.
“The ICH S6 regulatory guidance on Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals indicates that safety pharmacology studies should be completed to reveal any test article related functional effects on the major organ systems including cardiovascular, respiratory, and central nervous system,” said Tyler Speece, Director of Safety Pharmacology at Inotiv. “The cynomolgus macaque is frequently the only pharmacologically relevant species for the testing of biologics due to their anatomic and physiologic similarities to humans.”
Speece continued, “We’re pleased to offer combined telemetry study models that assess potential test article related effects on the cardiovascular and respiratory systems, performed simultaneously in the same animals—an added benefit of which aligns with the principles of the 3Rs: Replacement, Reduction and Refinement. Researchers can reduce the number of animals needed for testing, minimize distress caused by repeated testing, and ultimately improve animal welfare.”
Together with cardiopulmonary telemetry study offerings in other rodent and non-rodent species, Inotiv can now provide complete Good Laboratory Practice (GLP) safety pharmacology testing solutions to assist with the development of biologics as well as small molecules. With this newly added offering and available capacity, the Company expects to further enable clients to confidently navigate the regulatory landscape and accelerate the development of their products.
"Inotiv is dedicated to providing our clients with innovative and reliable solutions that meet their project needs," said John Sagartz, Chief Strategy Officer. "This expanded offering allows us to provide our clients with the high-quality, GLP safety pharmacology testing solutions they need by combining evaluation of cardiac and respiratory endpoints within the same study, thereby minimizing the need for separate experiments to achieve these goals."
About Inotiv
Inotiv, Inc. is a leading contract research organization dedicated to providing nonclinical and analytical drug discovery and development services and research models and related products and services. The Company’s products and services focus on bringing new drugs and medical devices through the discovery and preclinical phases of development, all while increasing efficiency, improving data, and reducing the cost of taking new drugs to market. Inotiv is committed to supporting discovery and development objectives as well as helping researchers realize the full potential of their critical R&D projects, all while working together to build a healthier and safer world. Further information about Inotiv can be found here: https://www.inotivco.com/.
This release may contain forward-looking statements that are subject to risks and uncertainties including, but not limited to, risks and uncertainties related to the impact of recent events related to non-human primate matters on the Company’s business, operations, results, financial condition, cash flows, and assets, the Company’s ability to comply with covenants under its credit agreement,changes in the market and demand for the Company’s products and services, the development, marketing and sales of products and services, changes in technology, industry and regulatory standards, the timing of acquisitions and the successful closing, integration and business and financial impact thereof, governmental regulations, inspections and investigations, claims and litigation against or involving the Company, its business and/or its industry, the impact of site closures and consolidations, expansion and related efforts, and various other market and operating risks, including those detailed in the Company's filings with the U.S. Securities and Exchange Commission.
