Understanding Nonclinical Auditory Safety Evaluations

//Understanding Nonclinical Auditory Safety Evaluations

Understanding Nonclinical Auditory Safety Evaluations

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
By |2014-03-17T14:56:41+00:00November 27th, 2012|News|Comments Off on Understanding Nonclinical Auditory Safety Evaluations

About the Author:

MPI Research, with global headquarters in Mattawan, Mich., provides safety evaluation, discovery, bioanalytical and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. The company offers comprehensive imaging solutions including preclinical imaging, radiochemistry, and data analysis. Scientific knowledge and experience, responsiveness, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world.