The ear is the only major organ that is not included on the FDA’s list of recommended tissues to test for toxicity as part of regulatory submission. 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. As part of an exclusive partnership with Turner Scientific, Sinclair Research believes that the potential for ototoxicity is not being adequately addressed and that evaluating such potential damage to hearing represents a large unmet need both patients and drug developers.
Built on more than 50 years of experience, Sinclair Research offers Ototoxicity research services to support biopharmaceutical, animal health and medical device development programs. Sinclair offers unparalleled expertise in all research models and is a pioneer in miniature swine research.
Through our partnership with Turner Scientific, an established leader in Ototoxicity, Sinclair offers GLP auditory safety testing to evaluate detect and define potential ototoxicity of any drug or chemical to cause damage to the ears. In addition, Sinclair Research now offers testing to evaluate efficacy of drugs in improving hearing and preventing hearing loss, reducing the risks and severity of tinnitus, and improving vestibular dysfunction.
Why partner with Sinclair Research?
As one of the largest nonclinical CROs in North America, Sinclair Research’s scientific and technical expertise can provide you with the Ototoxicity services you need, the data you expect, and the customer experience you deserve! Contact our team to discuss your upcoming research and meet with our scientific experts to discuss how to reach your next development milestone.
Our Ototoxicity studies include:
- Ototoxicity Research Services
- Behavioral audiogram and tinnitus testing
- General middle and inner ear hisopathology
- Multiple animal models
- Multiple noise exposure models
- Multiple drug delivery routes
Ototoxic side effects are common to many medications, including:
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as aspirin, Ibuprofen
- antibiotics such as kanamycin, neomycin, gentamycin
- Additional antibiotics such as erythromycin, vancomycin, and many others
- Diuretics such as furosemide, bumetanide
- Chemotherapeutic (cancer) agents such as bleomycine, cisplatin, carboplatinum, methotrexate
- Antimalarials such as chloroquine
- Cardiac medications such as propanolol, quinidine
- Anesthetics such as lidocaine, bupivacain
- Psychopharmacologic agents such as amitryptiline, benzodiazepines, bupropion, fluoxetine, imipramine, lithium
- Glucocorticoids such as prednisolone, ACTH