Elements and development processes for test methods in toxicology and human health-relevant life science research

Abstract

seems to be clear only to a fraction of researchers and stakeholders in the field. Only a subfraction of these feels confident about the development of a test method or about knowledge on all the steps in the lifecycle, including the use, of a test method.A common quick-fix for such knowledge gaps is to consult Wikipedia. There, a test method is defined as "a method for a test in science or engineering, such as a physical, chemical, or statistical test. It is a definitive procedure that produces a test result". Is this really helpful? Does it not feel like circular reasoning ("a test 1 Setting the scene It is a broadly accepted fact that test methods are important as research tools in toxicology, pharmacy, pharmacology, clinical chemistry, and many biomedical fields. There is also little dispute on the importance of data from test methods for diagnosis, quality control, efficacy estimates, and setting reference values for human, animal, and environmental safety. Given this background, it is astonishing that the fundamental definition of a test method

Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility

“…If all these elements are defined for a certain MPS, it can be considered a test method. More detailed definitions can be found elsewhere ( Collen et al., 2024 ; Leist et al., 2010 ).…”

Controversy on health-based guidance values for bisphenol A—the need of criteria for studies that serve as a basis for risk assessment

“…Even if the relationship of Th17 cells and some adverse effects would be known, the relevance and predictivity of the model concerning the human situation should be ascertained. Regulatory decisions should only be based on accepted scientific end-points that are considered relevant to humans (Cöllen et al 2024 ; Pallocca and Leist 2022 ). There are some obvious differences between humans and mice in immune system regulation, in metabolism, and in the microbiome.…”

Avoiding a reproducibility crisis in regulatory toxicology—on the fundamental role of ring trials

“…It addresses elements of a test method such as materials and reagents, test systems and standard operating procedures (SOPs). Recently, Cöllen and co-workers summarized all the key test method elements to be: The purpose, the test system, the test chemical exposure scheme, and the endpoint (Cöllen et al 2024 , Fig. 1 ).…”