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Using 21st Century Science to Improve Risk-Related Evaluations (2017) / Chapter Skim
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6 Model and Assay Validation and Acceptance
Pages 108-116

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From page 108...
... The committee emphasizes that valito the reproducibility of the method "within and between dation, although important, is not the only factor involved laboratories over time, when performed using the same in achieving regulatory acceptance of new alternative test protocol." The term relevance is meant to ensure the sci- methods. Furthermore, the committee notes that although entific underpinning of the test and of the outcome that it assay and model validation for toxicity testing is already is meant to evaluate so that it tests "the effect of interest an established process, other important disciplines, such 108
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From page 109...
... Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) was also European Union established in NIEHS to support ICCVAM in "the development and evaluation of new, revised, and alternative In the European Union, formal activities for validatmethods to identify potential hazards to human health and ing alternative approaches to animal testing started in 1991 the environment with a focus on replacing, reducing, or with creation of the European Centre for the Validation of refining animal use" (Casey 2016)
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From page 110...
... 30(Final) stipulated that "data generated in physiological realities of the human body and argued that the testing of chemicals in an OECD Member country in tests should be developed to provide more mechanistic accordance with OECD Test Guidelines and OECD Prin- information and thus help to establish causality.
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From page 111...
... • Guidance Document for Describing Non-Guideline In Vitro Test Methods (OECD 2014) Methods for Safety Assessment."2 This activity is pursu- Enabling Fit-for-Purpose Validation ing a mission to bring together the collective knowledge of scientists from academe, industry, and government with The challenge of finding an appropriate comparator an eye to the development of criteria to establish confi- to enable fit-for-purpose validation of new test methods is dence in using nonanimal methods to support regulatory considerable because disagreements about the quality of a decisions and to develop a framework organized around gold standard or about whether there is one are common.
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From page 112...
... In the European Union, a quality-assurance metrics and quality control of day-to- network of vetted laboratories that can conduct validaday operation are well defined (for example, OECD Per- tion reliably has been established as one way to address formance Based Test Guideline TG455) , and it is widely the challenge (European Union Network of Laboratories recognized that such information needs to be documented.
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From page 113...
... . Yet another alternative is to use nizations involved in assay and model validation should a consensus resulting from multiple tests as a benchmark develop clear guidance documents and training materials against which each test is evaluated and to assess varia- to support validation, such as training materials that cover tion about the consensus by using resampling techniques various technical aspects of good in vitro method develor meta-analysis (see Chapter 7)
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From page 114...
... 2002. Selection of test chemicals for the ECresulted in recommendations for the reporting of stud- VAM international validation study on in vitro embryotoxies that develop, validate, or update a prediction model, icity tests.
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From page 115...
... Joint Research Centre [on Interagency Coordinating Committee on the Validation of line]
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From page 116...
... 2007. Evaluation of diagnostic tests the European Centre for the Validation of Alternative when there is no gold standard.
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Key Terms

  • guidance document
  • alternative test
  • assay validation
  • alternative methods
  • gold standard

  • validation process
  • european union
  • toxicity testing
  • decision context
  • regulatory acceptance

  • oecd test
  • test chemicals
  • analytical validation
  • biomarker evaluation
  • animal testing

  • joint research
  • coordinating committee
  • european centre
  • multivariable prediction
  • cell culture

  • research centre
  • test guideline
  • validated test
  • novel test
  • vitro test

  • test guidelines
  • proposed test
  • evaluation process
  • releasing data
  • particular decision


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