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Related Experiment Videos

Ondansetron: pre-clinical safety evaluation.

M L Tucker1, M R Jackson, M D Scales

  • 1Pathology and Toxicology Division, Glaxo Group Research Limited, Ware, Hertsfordshire, U.K.

European Journal of Cancer & Clinical Oncology
|January 1, 1989
PubMed
Summary

Pre-clinical safety evaluations demonstrate ondansetron has an excellent safety profile. The only identified toxicity was central nervous system effects at near lethal doses, with no genotoxic, reproductive, or oncogenic potential.

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Area of Science:

  • Pharmacology and Toxicology
  • Drug Safety Assessment

Background:

  • Ondansetron is a widely used antiemetic medication.
  • Comprehensive pre-clinical safety data is crucial for drug approval and clinical use.

Purpose of the Study:

  • To conduct a thorough pre-clinical safety evaluation of ondansetron.
  • To identify any potential toxicities, genotoxic, reproductive, or oncogenic effects.

Main Methods:

  • A series of pre-clinical safety studies were performed.
  • These included single and repeat dose toxicity, reproduction, genotoxicity, oncogenicity, local irritancy, and hypersensitivity studies.

Main Results:

  • Ondansetron exhibited a very good overall safety profile.
  • The primary toxicity observed was central nervous system effects at near lethal doses.

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  • No genotoxic, reproductive, or oncogenic potential was detected.

    • Conclusions:

    • Ondansetron demonstrates a favorable pre-clinical safety profile.
    • The drug is considered safe for further clinical development based on these findings.