Preclinical CROs partner to provide GLP ototoxicity testing services
Together the companies will provide GLP auditory testing to evaluate efficacy, as well as potential ototoxicity of compounds and devices ahead of clinical trials and potential investigational new drug (IND) and/or investigational device exemption (IDE) approval.
The preclinical contract research organization (CRO) Turner Scientific specializes in hearing research, assessing ototoxicity potential, hearing loss, development of tinnitus, and balance/vestibular disorders.
Sinclair Research Center also is a preclinical CRO and offers animal efficacy models, toxicology services, as well as compliant research capabilities.
As Jeremy Turner, PhD, founder and chief scientific officer of Turner Scientific explained, the early is the only major organ not included on the US Food and Drug Administration’s (FDA) list of recommended tissues to test for toxicity.
“Since approximately one-third of all FDA approved drugs are associated with hearing loss or tinnitus as possible side effects, the potential for ototoxicity is both well-documented and not adequately addressed. Evaluating such potential damage to hearing represents a large unmet need of both patients and drug developers,” he said in a press release.
“Through this partnership with Turner Scientific, Sinclair Research now offers sponsors the ability to perform GLP ototoxicity studies and evaluate efficacy of otic drugs in improving hearing and preventing hearing loss, reducing the risks and severity of tinnitus, and improving vestibular dysfunction,” Guy Bouchard, DVM, President of Sinclair Research said in a statement.
