Development of a FDA-Approved Pharmaceutical to Treat Noise-Induced Hearing Loss
Abstract
The overall objective the work reported here was designed to obtain additional pre-clinical data required to prepare the FDA Briefing Book in support of Phase 1 a and 1 b studies. The technical objectives of this study have provided important efficacy and pharmacokinetic pre- clinical data in rats in support of our application for FDA clinical trials.
Document Details
- Document Type
- Technical Report
- Publication Date
- Aug 13, 2014
- Accession Number
- ADA624048
Entities
People
- Donald Ewert
- Richard Kopke
Organizations
- Hough Ear Institute