Acceptance criteria for new approach methods in toxicology and human health-relevant life science research - part I
Open accessAbstract
Every test procedure, scientific and non-scientific, has inherent uncertainties, even when performed according to a standard operating procedure (SOP). In addition, it is prone to errors, defects, and mistakes introduced by operators, laboratory equipment, or materials used. Adherence to an SOP and comprehensive validation of the test method cannot guarantee that each test run produces data within the acceptable range of variability and with the precision and accuracy determined during the method validation. We illustrate here (part I) why controlling the validity of each test run is an important element of experimental design. The definition and application of acceptance criteria (AC) for the validity of test runs is important for the setup and use of test methods, particularly for the use of new approach methods (NAM) in toxicity testing. AC can be used for decision rules on how to handle data, e.g., to accept the data for further use (AC fulfilled) or to reject the data (AC not fulfilled). The adherence to AC has important requirements and consequences that may seem surprising at first sight: (i) AC depend on a test method's objectives, e.g., on the types/concentrations of chemicals tested, the regulatory context, the desired throughput; (ii) AC are applied and documented at each test run, while validation of a method (including the definition of AC) is only performed once; (iii) if AC are altered, then the set of data produced by a method can change. AC, if missing, are the blind spot of quality assurance: Test results may not be reliable and comparable. The establishment and uses of AC will be further detailed in part II of this series.
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The usual procedure is to set acceptance criteria that QCs have to meet.
“The usual procedure is to set AC that QCs have to meet (Holzer et al., 2023).”
From Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility (2024) · cites this paper as Holzer et al., 2023
To assure the quality of test runs, acceptance criteria can be defined.
“To assure the quality of test runs, so-called AC can be defined (Holzer et al., 2023).”
From Recommendations on fit-for-purpose criteria to establish quality management for microphysiological systems and for monitoring their reproducibility (2024) · cites this paper as Holzer et al., 2023
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- Authors
- Holzer, A.-K.
- Affiliations
- University of Konstanz (DE)
- Corresponding author
- Holzer, Anna-Katharina
- Venue
- ALTEX
- Publisher
- ALTEX Edition
- Published
- 2023
- Volume
- 40
- Issue
- 4
- Pages
- 706-712
- ISSN
- 0946-7785 (ISSN-L)
- 1868-596X
- OpenAlex
- W4387964956
- Cited by
- 8
- References
- 24
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 4
- FWCI
- 2.45
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- ALTEX (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Leiden Repository (Leiden University) (submittedVersion, cc-by)
- KOPS (University of Konstanz) (submittedVersion)
- OpenAgrar (submittedVersion, cc-by)
- Funders
- European Commission (964518, 964537, RISK-HUNT3R, HORIZON2020, 101057014)
- Bundesministerium für Bildung und Forschung
- Universität Konstanz
- Topics
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Keywords
- acceptance criteria, new approach methodologies, toxicity testing, method validation, quality assurance, experimental design, data rejection, precision and accuracy, test reliability
- MeSH terms
- Biological Science Disciplines, Humans, Research Design, Toxicity Tests
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