Auditory safety evaluations are recommended for any drug administered into the middle ear or that may come in contact with the middle or inner ear tissues. In addition to otically administered compounds, some classes of systemically administered drugs should also be considered for evaluation.
Auditory safety evaluations require executing a unique set of functions to obtain the appropriate measures to definitively characterize the auditory safety of drugs. Evaluating ototoxicity as part of the overall safety program is an area of unmet need within nonclinical research. To meet this need, MPI Research has taken steps to develop and validate the procedures required to perform these study types under Good Laboratory Practices.
This presentation will explore requisite study designs and detailed procedures that are routinely employed to support scientific and regulatory best practices in assessing auditory safety.
Key topics will include
- Endpoints required to appropriately assess auditory safety
- Variations on study designs to address unique circumstances of various drug classes
- Auditory safety techniques used for evaluation