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Updated: May 31, 2025

A Methodological Approach to Non-invasive Assessments of Vascular Function and Morphology

A Methodological Approach to Non-invasive Assessments of Vascular Function and Morphology

Published on: February 7, 2015

Validation framework for in vivo digital measures.

Szczepan W Baran¹, Susan E Bolin², Stefano Gaburro³

¹VeriSIM Life, San Francisco, CA, United States.

Frontiers in Toxicology

|January 23, 2025

Summary

This summary is machine-generated.

This study adapts the Digital Medicine Society

Keywords:

3Rs (replace reduce refine)digital biomarkers drug discovery and development preclinical rodents translation validation verification

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Area of Science:

Pharmaceutical R&D
Digital Health Technologies
Preclinical Research

Background:

Digital measures offer enhanced efficiency in drug discovery.
The Digital Medicine Society's V3 Framework validates clinical digital measures.
Adapting this framework for preclinical research is crucial.

Purpose of the Study:

To adapt the V3 Framework for preclinical digital measures.
To ensure reliability and relevance of digital tools in animal models.
To support robust and translatable drug discovery.

Main Methods:

Verification: Ensuring accurate data capture and storage.
Analytical Validation: Assessing algorithm precision for biological metrics.
Clinical Validation: Confirming relevance to animal model states.

Main Results:

A structured approach for preclinical digital measure validation is proposed.
The adapted framework addresses verification, analytical, and clinical validation.
Stakeholder collaboration enhances digital measure reliability.

Conclusions:

Widespread adoption of the adapted V3 Framework will improve preclinical digital measures.
This enhances the translatability of drug discovery and development.
Reliable digital measures accelerate therapeutic innovation.