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Repeat Dose Toxicity Testing

Repeat Dose Toxicity Studies for Your New Drug Candidate

Repeat dose or chronic toxicity studies help evaluate the effects of repeat administration of a new drug candidate over a defined period of time. Chronic toxicity studies help you select proper dosing amounts for GLP studies and identify potential target organs affected by the compound. As an experienced partner in general toxicology testing, WuXi AppTec can help you build an in vitro ADME program that includes the correct repeat dose toxicity studies for your needs.

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Expert Repeat Dose Toxicity Studies

WuXi AppTec offers end-to-end toxicology testing for all stages of the drug development lifecycle. Our expert team helps you design repeat dose toxicity studies with the right toxicological species, dose level, routes of administration, analyses, and regulatory support.

SPECIES

  • Canine
  • Mouse
  • Rat
  • Rabbit
  • NHP
  • Swine

ROUTE OF ADMINISTRATION

  • Intravenous (bolus, infusion)
  • Oral (gavage, capsule) and nasogastric (for NHPs)
  • Topical
  • Intramuscular
  • Subcutaneous
  • Intradermal
  • Ocular (including systemic, topical, subconjunctival, intravitreal, sub-retinal and retrobulbar)
  • Implant
  • Other (upon request)
    • Intrathecal
    • Intra-articular
    • Intraperitoneal
    • Intra-arterial

Repeat Dose Toxicity Data

Repeat dose toxicity studies generate data that deepen researchers’ understanding of dose and toxicity for a given compound. This chronic toxicity data helps identify correct dosing for the pivotal later stage GLP studies.

Example Chart/Table

Repeat dose toxicity studies are a critical part of the drug development lifecycle, playing important roles through the discovery, preclinical to IND, and clinical stages.

Repeat Dose Toxicity Studies FAQ

What are repeat dose toxicity studies?

Repeat dose toxicity studies test the safety of a new drug candidate by exposing animals to repeated doses of the compound and monitoring for signs of toxicity over the course of 14-28 days.

Why are repeat dose toxicity studies necessary?

Repeat dose toxicity studies evaluate the effects of repeat administration over a defined period of time. The studies will provide detailed information about the potential target organs of toxicity, the exposure, as well as the potential of toxic effects.

How do repeat dose toxicity studies add value to my testing program?

The studies will provide information about the toxicity of the organs effected by the compound. The repeated-dose toxicity studies are essential for the quantitative risk assessment of drug molecules.