Preclinical Animal Study

A preclinical animal study is a type of scientific research conducted prior to initiating clinical trials in humans. Its primary aim is to assess the safety, toxicity, pharmacokinetics, and often the preliminary efficacy of a proposed medical intervention.

• To determine if a new drug, therapy, or device is safe and potentially effective before human testing.
• To support regulatory submissions (e.g., FDA IND application).

• Use of animals that mimic human disease or relevant physiological conditions.
• Common species: mice, rats, rabbits, pigs, non-human primates.
• Models must demonstrate:
  • Biological relevance
  • Predictive validity for human outcomes

• Toxicity studies (acute, subacute, chronic)
• Histopathological evaluation
• Organ function monitoring
• Drug absorption, distribution, metabolism, excretion (ADME)
• Behavioral and neurological testing (in neuro studies)

• Compliance with ethical standards and animal welfare laws
• Implementation of the 3Rs:
  1. Replacement (use alternatives when possible)
  2. Reduction (minimize number of animals)
  3. Refinement (optimize procedures to reduce suffering)

• Preclinical results are required to:
  • Define starting dose in human trials
  • Justify trial design and risk mitigation
  • Obtain approval for first-in-human studies

Tags: preclinical, animal study, safety, toxicity, IND, pharmacology, translational research