Best Practices for the Conduct of Preclinical Ototoxicity Evaluations
Ototoxicity leading to inner ear damage is a common form of hearing loss. Current guidance for human drug development does not require auditory assessment, resulting in more than 200 marketed medications that are ototoxic.
This webinar, presented by CBSET, will provide a look into ototoxicity assessment from screening to GLP studies with FDA guidelines. We will gather experts of the field of auditory safety preclinical assessment: Aurore Marie, Global Head of R&D Operations Management at CILcare; John Keating, Director of Pathology at CBSET; and Christopher Toscano, of the Office of New Drugs at the Center for Drug Evaluation and Research, at the FDA.
This webinar will help you learn:
- Why it is important to run ototoxicity assessments at an early phase and what screening models are available
- What the animal models and the sensitive & specific techniques are for assessing ototoxicity in GLP and non-GLP preclinical studies
- What the current FDA regulatory guidelines are
Join us on 20 January, 2022 at 12 pm EST / 6 pm CET and raise your questions during the Q&A!
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