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Updated: Sep 4, 2025

Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data
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Technical framework for enabling high quality measurements in new approach methodologies (NAMs).

Elijah J Petersen1, John T Elliott1, John Gordon2

  • 1National Institute of Standards and Technology (NIST), Gaithersburg, MD, USA.

ALTEX
|July 22, 2022
PubMed
Summary

New approach methodologies (NAMs) offer alternatives to animal testing. This study introduces a technical framework to enhance the reproducibility of laboratory-based NAMs through quality tools and step-by-step protocol refinement.

Keywords:
BenchMarks seriesbasic quality toolsin vitro methodsreliabilityreproducibilitystandardization

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Area of Science:

  • Toxicology
  • Biotechnology
  • Laboratory Science

Background:

  • New approach methodologies (NAMs) are in vitro, in chemico, and in silico methods to reduce animal testing.
  • Reproducibility is crucial for laboratory-based NAMs, yet a comprehensive technical framework for integrating measurement quality is lacking.

Discussion:

  • This manuscript presents a technical framework for refining NAM protocols using basic quality tools.
  • The framework involves conceptual analysis of variability, within-laboratory evaluation, statistical analysis, and method transferability assessment.

Key Insights:

  • The proposed framework guides assay design choices, including in-process controls and replicate numbers.
  • Implementing this framework can optimize NAM reproducibility for research and regulatory purposes.

Outlook:

  • Further development and adoption of this framework can enhance the reliability and acceptance of NAMs.
  • This approach supports the broader goal of reducing animal testing in scientific research.