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Predicting the Need for a Tier II Ototoxicity Study From Early Renal Function Data.

David V Gauvin1, Zachary J Zimmermann1, Joshua Yoder1

  • 11 Neurobehavioral Sciences Department, Charles River Laboratories, Inc, Mattawan, MI, USA.

International Journal of Toxicology
|June 22, 2019
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Summary

Early detection of drug-induced ototoxicity is crucial. Monitoring kidney function in early drug development studies may signal potential hearing damage, enabling safer drug candidates.

Keywords:
acute kidney injurybiomarkersnephrotoxicityototoxicitypredictive index

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Area of Science:

  • Pharmacology
  • Toxicology
  • Drug Development

Background:

  • Many drugs, including antibiotics and chemotherapies, can cause kidney (nephrotoxicity) and ear (ototoxicity) damage.
  • The precise mechanisms of this cellular damage are not fully understood.
  • Early detection of potential ototoxicity is vital for developing safer medications.

Purpose of the Study:

  • To emphasize the importance of early identification of drug-induced ototoxicity during drug development.
  • To highlight the need for understanding the cellular and molecular mechanisms of ototoxicity.
  • To propose using kidney function biomarkers as an early indicator for auditory function testing.

Main Methods:

  • Review of historical drug-induced toxicities.
  • Analysis of standard early investigational new drug (IND)-enabling studies.
  • Correlation of renal function monitoring with potential ototoxic effects.

Main Results:

  • Kidney function indices in early studies may serve as preliminary indicators of ototoxicity.
  • Understanding molecular mechanisms is key to preventing ototoxicity.
  • Early auditory function assays can help identify safer drug candidates.

Conclusions:

  • Integrating ototoxicity assessments early in drug development is essential.
  • Biomarkers for nephrotoxicity should prompt investigation into ototoxic potential.
  • This approach can lead to safer drugs with better patient compliance.