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.

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Document Details

Document Type
Technical Report
Publication Date
Aug 13, 2014
Accession Number
ADA624048

Entities

People

  • Donald Ewert
  • Richard Kopke

Organizations

  • Hough Ear Institute

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Antioxidants
  • Biomedical Research
  • Blood
  • Blood Plasma
  • Catheters
  • Cell Count
  • Clinical Trials
  • Cysteine
  • Drug Combinations
  • Frequency
  • Hearing Disorders
  • Hearing Loss
  • High Pressure
  • Jugular Vein
  • Liquid Chromatography
  • Medical Personnel
  • Veins

Fields of Study

  • Medicine

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