Acceptance criteria for new approach methods in toxicology and human health-relevant life science research – part I

Holzer, Anna-Katharina

doi:10.14573/altex.2310021

Cited by 4 publications

(5 citation statements)

References 18 publications

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“…QC, which involves test procedures implemented at various checkpoints, is essential to guarantee the reproducibility of each step in the production process and the consistent performance of individual experiments. The usual procedure is to set AC that QCs have to meet ( Holzer et al., 2023 ). The QM plan also defines which QC needs to be performed at which time, in which frequency, and under which conditions.…”

Section: Qm For Complex Culture Systemsmentioning

confidence: 99%

“…The test system describes the biological key properties of a culture type, e.g., a liver organoid, a cerebral organoid, or a muscle-nerve assembloid. It should include details of all physical (e.g., size, spatial cellular arrangement), chemical (e.g., matrix components, scaffold), and biological elements (e.g., percentages of different cells, cell source) ( Holzer et al., 2023 ; Krebs et al., 2020 ). An MPS is, in most cases, a test system.…”

Section: Qm For Complex Culture Systemsmentioning

confidence: 99%

“…It determines the validity/fit-for-purpose of a test method as such, but it cannot guarantee that each test run (i.e., each experiment using an MPS) yields reliable results. To assure the quality of test runs, so-called AC can be defined ( Holzer et al., 2023 ).

…”

Section: Qm For Complex Culture Systemsmentioning

confidence: 99%

See 2 more Smart Citations

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

Pamies,

Ekert,

Zurich

et al. 2024

Stem Cell Reports

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Section: Qm For Complex Culture Systemsmentioning

confidence: 99%

Section: Qm For Complex Culture Systemsmentioning

confidence: 99%

See 1 more Smart Citation

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

Pamies,

Ekert,

Zurich

et al. 2024

Stem Cell Reports

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“…Finally, validation may ensure that a method is transparent, transferable and controllable for each run. For the latter purpose, acceptance criteria may be defined (Holzer et al, 2023). The word validation is used here in its broadest sense as a process to obtain information on how reliable the test method is, how well the prediction model works, and how well the purpose of the test method is fulfilled.…”

Section: Discussionmentioning

confidence: 99%

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

2024

ALTEX

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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

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“…Validation is a scientifically anchored process that serves to demonstrate the reliability and relevance of a method for a particular purpose, for example, hazard classification or safety assessment of uses of chemicals (Bruner et al 1996 , Bas et al 2021 , Holzer et al 2023a , 2023b ). Validation is an essential requirement for TGs such that they can be used under MAD in all OECD member countries (as well as non-member provisional and full adherents), and thus meet legal obligations for all stakeholders.…”

Section: The Current State Of Validationmentioning

confidence: 99%

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

Jacobs,

Hoffmann,

Hollnagel

et al. 2024

Arch Toxicol

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The ongoing transition from chemical hazard and risk assessment based on animal studies to assessment relying mostly on non-animal data, requires a multitude of novel experimental methods, and this means that guidance on the validation and standardisation of test methods intended for international applicability and acceptance, needs to be updated. These so-called new approach methodologies (NAMs) must be applicable to the chemical regulatory domain and provide reliable data which are relevant to hazard and risk assessment. Confidence in and use of NAMs will depend on their reliability and relevance, and both are thoroughly assessed by validation. Validation is, however, a time- and resource-demanding process. As updates on validation guidance are conducted, the valuable components must be kept: Reliable data are and will remain fundamental. In 2016, the scientific community was made aware of the general crisis in scientific reproducibility—validated methods must not fall into this. In this commentary, we emphasize the central importance of ring trials in the validation of experimental methods. Ring trials are sometimes considered to be a major hold-up with little value added to the validation. Here, we clarify that ring trials are indispensable to demonstrate the robustness and reproducibility of a new method. Further, that methods do fail in method transfer and ring trials due to different stumbling blocks, but these provide learnings to ensure the robustness of new methods. At the same time, we identify what it would take to perform ring trials more efficiently, and how ring trials fit into the much-needed update to the guidance on the validation of NAMs.

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Acceptance criteria for new approach methods in toxicology and human health-relevant life science research – part I

Cited by 4 publications

References 18 publications

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

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

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

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

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