Best Practices for the Conduct of Preclinical Ototoxicity Evaluation: ACT Talking Tox replay

We are pleased to share the replay of the Talking Tox Webinar, which took place as part of ACT’s 42nd Virtual Annual Meeting, featuring experts from the CBSET, CILcare and the FDA.

View the webinar replay to learn more about preclinical ototoxicity evaluation:

Ototoxicity resulting in inner ear damage is a leading cause of acquired hearing loss worldwide. About 1 billion people around the world are at risk of avoidable hearing loss according to the World Health Organization. This could be minimized or avoided by early testing hearing functions in the preclinical phase.

While the assessment of ototoxicity is defined for otic drug products, current guidance for human drug development does not specifically mention the assessment of auditory structure & function. Except for otic formulations, the nonclinical assessment for ototoxicity of drug candidates in general toxicology studies is limited. Unfortunately, this has resulted in more than 200 ototoxic marketed medications

This webinar, presented by experts in the field, provides a look into ototoxicity assessment from early-stage screening to GLP studies and addresses current guidelines and recommendations to successfully build your dossier. It will help you learn:

  • Why it is important to run ototoxicity assessments in the early phase and what are the available models used in screening with an emphasis on cochlear explants
  • What the animal models and the sensitive & specific techniques are for assessing ototoxicity in GLP and non-GLP preclinical studies that can provide reliable safety data, with a focus on:
    • ABR measurements: reproducibility, throughput, data management
    • Histology assessment with cochleogram
    • The current regulatory guidelines for non-clinical safety auditory assessment