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Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

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Published on: June 17, 2015

Toxicity testing is evolving!

Ida Fischer¹, Catherine Milton¹, Heather Wallace¹

¹Institution of Medical Sciences, University of Aberdeen, Aberdeen AB25 2ZD, UK.

Toxicology Research

|May 23, 2020

Summary

This summary is machine-generated.

New toxicity testing methods, known as new approach methodologies (NAMs), are crucial for chemical safety. Despite scientific advances, regulatory acceptance of these sustainable alternatives to animal testing is slow.

Keywords:

21st century toxicology NAMs Q(SAR)TOX21 TOX21c animal testing drug development high-throughput screening innovation new approach methodologies organ-on-a-chip pharmaceuticals read-across regulatory toxicology risk assessment toxicity testing toxicology

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Area of Science:

Environmental toxicology
Regulatory science
Chemical safety assessment

Background:

Increasing chemical substance use necessitates efficient management and robust toxicity testing.
Traditional animal-based toxicity testing faces sustainability concerns.
A critical need exists for reliable, sustainable, and regulatory-accepted toxicity testing methods.

Purpose of the Study:

To review European initiatives for developing new approach methodologies (NAMs) for pharmaceutical toxicity testing.
To address the lag in legislation and acceptance of NAMs despite scientific progress.
To present a novel systematic approach for 21st-century toxicity testing.

Main Methods:

Review of European initiatives for NAMs development.
Analysis of current regulatory frameworks and acceptance of NAMs.
Presentation of a systematic approach for toxicity testing methodology.

Main Results:

Numerous global initiatives aim to develop NAMs.
Legislation and regulatory acceptance of NAMs are not keeping pace with scientific advancements.
A novel systematic approach is proposed to support modern toxicity testing.

Conclusions:

There is a significant gap between the scientific availability of NAMs and their regulatory implementation.
Accelerated legislative and societal acceptance of NAMs is essential for sustainable chemical safety.
The proposed systematic approach offers a pathway for advancing toxicity testing methodologies.