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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Updated: Dec 16, 2025

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Advancing human health risk assessment.

Anna Lanzoni1, Anna F Castoldi1, George En Kass1

  • 1European Food Safety Authority IT.

EFSA Journal. European Food Safety Authority
|July 7, 2020
PubMed
Summary

The traditional human health risk assessment needs an overhaul due to ethical and scientific limitations. A new paradigm is required for reliable, animal-free hazard assessments using mechanistic understanding and exposure data.

Keywords:
alternative methodsepidemiologyexposurefood safetymechanistic studiesrisk assessment

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Area of Science:

  • Toxicology
  • Risk Assessment
  • Exposure Science

Background:

  • Current human health risk assessment is resource-intensive, unreliable, and often animal-based.
  • It lacks mechanistic understanding of toxicity and reproducibility.
  • Ethical demands necessitate a paradigm shift.

Purpose of the Study:

  • To outline the need for a new paradigm in human health risk assessment.
  • To propose a shift towards animal-free, mechanistic, and data-driven testing strategies.
  • To identify requirements for advancing risk assessment science.

Main Methods:

  • Discussion and synthesis of ideas presented at EFSA's third Scientific Conference.
  • Focus on integrating exposure science and epidemiological data.
  • Emphasis on mechanistic understanding of toxicity.

Main Results:

  • The current risk assessment model faces significant challenges.
  • A paradigm shift requires new philosophies, data accessibility, and multidisciplinary expertise.
  • Enhanced collaboration and flexible regulations are crucial.

Conclusions:

  • A transition to reliable, animal-free hazard and risk assessments is essential.
  • This requires re-engineering data, capacity building, and stakeholder dialogue.
  • Advancing risk assessment science necessitates a commitment to change and flexible funding.