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  3. Reimagining Human-centric Drug Development With New Approach Methodologies.
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  3. Reimagining Human-centric Drug Development With New Approach Methodologies.

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Reimagining human-centric drug development with new approach methodologies.

Xuekun Wu1,2, Matthew A Wu1, James Zou3,4

  • 1Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA, USA.

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|April 16, 2026

View abstract on PubMed

Summary
This summary is machine-generated.

New approach methodologies (NAMs) bridge the gap between preclinical models and human biology, improving drug development. These human-centric methods, supported by regulatory changes, offer a more predictive and ethical path forward.

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Area of Science:

  • Biomedical research
  • Drug development
  • Toxicology

Background:

  • Most drug candidates fail in clinical trials due to limitations in preclinical models.
  • A significant gap persists between animal models and human biology.
  • Technological advancements necessitate new methods in drug evaluation.

Purpose of the Study:

  • To review emerging biological and computational New Approach Methodologies (NAMs).
  • To examine the integration of NAMs in reshaping drug development.
  • To discuss regulatory and ethical frameworks for NAM implementation.

Main Methods:

  • Synthesis of current biological and computational NAMs.
  • Analysis of regulatory reforms, including the FDA Modernization Act 3.0.
  • Examination of ethical considerations for human-centered drug development.

    • Main Results:

    • NAMs, including human-derived cells and AI, offer a paradigm shift.
    • NAMs are positioned to complement or replace animal testing.
    • Integration of NAMs promises more predictive and efficient drug development.

    Conclusions:

    • NAMs represent a crucial transition towards human-centric drug development.
    • Regulatory and ethical frameworks are essential for successful NAM adoption.
    • A roadmap is proposed for embedding NAMs into a predictive and ethical infrastructure.