The Principles of Weight of Evidence Validation of Test Methods and Testing Strategies

Balls, Michael; Amcoff, Patric; Bremer, Susanne; Casati, Silvana; Coecke, Sandra; Clothier, Richard H.; Combes, Robert; Corvi, Raffaella; Curren, Rodger; Eskes, Chantra; Fentem, Julia H.; Gribaldo, Laura; Halder, Marlies; Hartung, Thomas; Hoffmann, Sebastian; Schechtman, Leonard M.; Scott, Laurie; Spielmann, Horst; Stokes, William S.; Tice, Raymond R.; Wagner, Drew; Zuang, Valérie

doi:10.1177/026119290603400604

Cited by 58 publications

(38 citation statements)

References 25 publications

(17 reference statements)

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“…A more flexible approach to assay validation would facilitate the evolution of testing toward a more mechanistic understanding of toxicity endpoints; the form the validation should take is a point of discussion and deliberation (Balls et al, 2006; Corvi et al, 2006). For nonregulatory use of assays, preliminary data-gathering, and exploration of mechanisms, at a minimum some general guidance on assay performance appears warranted for intended assays.…”

Section: Developing the Science Base And Assays To Implement The Visionmentioning

confidence: 99%

Toxicity Testing in the 21st Century: A Vision and a Strategy

Krewski

Acosta

Andersen

et al. 2010

Journal of Toxicology and Environmental Health, Part B

789

475

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With the release of the landmark report Toxicity Testing in the 21st Century: A Vision and a Strategy, the U.S. National Academy of Sciences, in 2007, precipitated a major change in the way toxicity testing is conducted. It envisions increased efficiency in toxicity testing and decreased animal usage by transitioning from current expensive and lengthy in vivo testing with qualitative endpoints to in vitro toxicity pathway assays on human cells or cell lines using robotic high-throughput screening with mechanistic quantitative parameters. Risk assessment in the exposed human population would focus on avoiding significant perturbations in these toxicity pathways. Computational systems biology models would be implemented to determine the dose-response models of perturbations of pathway function. Extrapolation of in vitro results to in vivo human blood and tissue concentrations would be based on pharmacokinetic models for the given exposure condition. This practice would enhance human relevance of test results, and would cover several test agents, compared to traditional toxicological testing strategies. As all the tools that are necessary to implement the vision are currently available or in an advanced stage of development, the key prerequisites to achieving this paradigm shift are a commitment to change in the scientific community, which could be facilitated by a broad discussion of the vision, and obtaining necessary resources to enhance current knowledge of pathway perturbations and pathway assays in humans and to implement computational systems biology models. Implementation of these strategies would result in a new toxicity testing paradigm firmly based on human biology.

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Section: Developing the Science Base And Assays To Implement The Visionmentioning

confidence: 99%

Toxicity Testing in the 21st Century: A Vision and a Strategy

Krewski

Acosta

Andersen

et al. 2010

Journal of Toxicology and Environmental Health, Part B

789

475

View full text Add to dashboard Cite

show abstract

“…[4849] The opinions of government regulators strongly influence the extent to which private companies use available alternatives. The various national and international bodies for validation and approval of in vitro methodologies include Organisation for Economic Co-operation and Development (OECD), European Centre for the Validation of Alternative Test Methods (ECVAM), the Interagency Coordinating Committee for the Validation of Alternative Methods in the US (ICCVAM), Japanese Center for the Validation of Alternative Methods (JaCVAM), KorCVAM in Korea and BraCVAM in Brazil.…”

Section: Alternatives To Animal Experimentationmentioning

confidence: 99%

“…The various national and international bodies for validation and approval of in vitro methodologies include Organisation for Economic Co-operation and Development (OECD), European Centre for the Validation of Alternative Test Methods (ECVAM), the Interagency Coordinating Committee for the Validation of Alternative Methods in the US (ICCVAM), Japanese Center for the Validation of Alternative Methods (JaCVAM), KorCVAM in Korea and BraCVAM in Brazil. [4950] The International Cooperation on Alternative Test Methods (ICATM) was created in 2009 as a collaboration between validation bodies from Europe, USA, Canada, Japan and Korea. Approximately 50 alternative methods and testing strategies have been developed, validated and/or accepted by international regulatory authorities.…”

Section: Alternatives To Animal Experimentationmentioning

confidence: 99%

Animal use in pharmacology education and research: The changing scenario

2014

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The use of animals in research and education dates back to the period when humans started to look for ways to prevent and cure ailments. Most of present day's drug discoveries were possible because of the use of animals in research. The dilemma to continue animal experiments in education and research continues with varied and confusing guidelines. However, the animal use and their handling vary in each laboratory and educational institution. It has been reported that the animals are being subjected to painful procedures in education and training unnecessarily. The extensive use of animals in toxicity studies and testing dermatological preparations has raised concerns about the ways animals are sacrificed for these “irrelevant experiments”. On the other side of the coin are scientists who advocate the relevant and judicious use of animals in research so that new discoveries can continue. In this review, we discuss the evolution of the use of animals in education and research and how these have been affected in recent times owing to concerns from animal lovers and government regulations. A number of computer simulation and other models have been recommended for use as alternatives to use of animals for pharmacology education. In this review we also discuss some of these alternatives.

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“…All approaches have their pros and cons, and consensus is best based on multiple approaches in what is termed weight of evidence. Given that extensive controlled testing of EDCs on humans is not possible, weight of evidence is defined as "consideration made in a situation where there is uncertainty, and which is used to ascertain whether the evidence or information surrounding one side of a cause or argument is greater than that supporting the other side" [4]. …”

Section: What Is Hazard?mentioning

confidence: 99%

An Introduction to the Challenges for Risk Assessment of Endocrine Disrupting Chemicals

Darbre¹

2015

Endocrine Disruption and Human Health

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The Principles of Weight of Evidence Validation of Test Methods and Testing Strategies

Cited by 58 publications

References 25 publications

Toxicity Testing in the 21st Century: A Vision and a Strategy

Toxicity Testing in the 21st Century: A Vision and a Strategy

Animal use in pharmacology education and research: The changing scenario

An Introduction to the Challenges for Risk Assessment of Endocrine Disrupting Chemicals

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