Inotiv, Inc. announced 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."
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