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Related Concept Videos

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Toxicity Testing in Animals

Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...
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The development of transgenic, knockout, and knock-in mice has led to an exponential increase in their use as model organisms in research,...

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Related Experiment Video

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A Robust Pneumonia Model in Immunocompetent Rodents to Evaluate Antibacterial Efficacy against S. pneumoniae, H. influenzae, K. pneumoniae, P. aeruginosa or A. baumannii
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Animal models for microbicide safety and efficacy testing.

Ronald S Veazey1

  • 1Tulane National Primate Research Center, Tulane University School of Medicine, Covington, LA 70433, USA. rveazey@tulane.edu

Current Opinion in HIV and AIDS
|May 24, 2013
PubMed
Summary

Animal models accurately predict the safety and efficacy of HIV prevention strategies like microbicides. Recent human trials confirm these predictions, validating animal models for future drug development and selection.

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Area of Science:

  • * Infectious Disease Research
  • * Pharmacology and Toxicology
  • * Translational Medicine

Background:

  • * Historical skepticism regarding the predictive utility of animal models for human immunodeficiency virus (HIV) prevention strategies.
  • * Emerging evidence suggests a stronger correlation between animal model outcomes and human trial results for microbicide candidates.

Purpose of the Study:

  • * To re-evaluate the predictive value of animal models in the context of HIV prevention strategies.
  • * To reconcile discrepancies between animal model data and human trial outcomes for microbicides.
  • * To establish the reliability of animal models for prospective selection of novel microbicide candidates.

Main Methods:

  • * Review of recent human phase 3 microbicide trials and their correlation with prior animal model studies.
  • * Analysis of factors contributing to past discrepancies, including study design and human trial noncompliance.
  • * Ongoing investigations utilizing murine and nonhuman primate models for tissue distribution, efficacy duration, and safety assessments.

Main Results:

  • * Topical vaginal gels and oral antiretroviral prophylaxis have demonstrated efficacy in preventing sexual HIV transmission in humans, as predicted by animal models.
  • * Discrepancies between animal and human results are increasingly attributed to inadequate study design or noncompliance in human trials.
  • * Successful human microbicide studies have validated the predictive accuracy of animal models for safety and efficacy.

Conclusions:

  • * Animal models are validated tools for predicting the safety and efficacy of HIV prevention microbicides.
  • * Prospective use of validated animal models can accelerate the selection of safer, more effective, and durable microbicide candidates for human trials.
  • * Ongoing research continues to refine the application of animal models in HIV prevention research.