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This study critiques animal testing in biomedical research, highlighting scientific and ethical flaws. It proposes a paradigm shift to human-centered New Approach Methodologies (NAMs) for more predictive and ethical research.

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Area of Science:

  • Biomedical Ethics
  • Translational Science
  • Toxicology

Background:

  • Current animal experimentation faces significant scientific and ethical challenges.
  • The
  • The welfarist approach to animal research is ethically insufficient and perpetuates instrumentalization.

Purpose of the Study:

  • To critically analyze the limitations of animal models in biomedical research.
  • To propose a paradigm shift towards human-centered methodologies.
  • To advocate for the adoption of New Approach Methodologies (NAMs).

Main Methods:

  • Critical analysis of existing literature on animal experimentation.
  • Evaluation of scientific deficiencies, including the
  • Review of ethical frameworks governing animal research.

Main Results:

  • Animal models exhibit low predictive value for human outcomes due to interspecies biological differences.
  • The "Three Rs" framework provides only incremental improvements.
  • A significant scientific and ethical re-evaluation of research methods is necessary.

Conclusions:

  • A paradigm shift to human-relevant New Approach Methodologies (NAMs) offers a more scientifically robust and ethically sound alternative.
  • Modernizing regulatory structures and fostering ethical responsibility are crucial for this transition.
  • Adopting NAMs is a scientific imperative for advancing human health and promoting ethical research practices.