The Principles of Validation and the ECVAM Validation Process

Worth, Andrew; Balls, Michael

doi:10.1177/026119290403201s105

Cited by 15 publications

(5 citation statements)

References 21 publications

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“…The translations of both BSQ and FAS questionnaires followed an established international standard 15 involving permissions to translate from copyright holders. Following this, the original English versions of both questionnaires were each translated into the Polish language by two independent translators.…”

Section: Methodsmentioning

confidence: 99%

Body Shape Questionnaire-34 (BSQ) and Functionality Appreciation Scale (FAS) - pertinent body image screening tools: Creation and validation of Polish language versions

Yurtsever¹,

Matusiak

Szepietowska

et al. 2022

Science Progress

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Objective: Body image is defined as the perception of one's own body. While positive body image has a positive impact on quality of life, self-dissatisfaction may lead to depression, anxiety and low self-esteem. Body image might be quantified and evaluated: relevant instruments include the Body Shape Questionnaire (BSQ) and the Functionality Appreciation Scale (FAS). This study was designed to translate and evaluate the psychometric properties of the Polish versions of these instruments. Methods: Translation (both forward and backward) from the original English versions of the questionnaires met international standards. Internal consistency and test-retest reliability are reported from 89 participants for the BSQ and 103 for the FAS. The participants also completed the Polish versions of the Body Image Quality of Life Inventory (BIQLI) and the Body Appreciation Scale-2 (BAS-2) to explore convergent validity. Results: Both, Polish versions of the BSQ and the FAS demonstrated good internal consistency and reproducibility. Convergent validity revealed a moderate relationship between the BSQ and the BIQLI scores, and a strong one between the FAS and the BAS-2 scores. Conclusion: Polish versions of both BSQ and FAS questionnaires showed sufficiently strong psychometric properties to support their use in clinical and research work with Polish speaking patients.

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Section: Methodsmentioning

confidence: 99%

Body Shape Questionnaire-34 (BSQ) and Functionality Appreciation Scale (FAS) - pertinent body image screening tools: Creation and validation of Polish language versions

Yurtsever¹,

Matusiak

Szepietowska

et al. 2022

Science Progress

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show abstract

“…For skin sensitisation, a full analysis of applicability domain would include an analysis of the mechanistic reactivity domain associated with each chemical (Aptula et al, 2005, Aptula and Roberts, 2006, Roberts et al, 2007. However, definition and consideration of the physicochemical property ranges, such as compound solubility, is a key step in the assessment of technical limitations to assist in the evaluation and ultimate validation of an in vitro assay (Bruner et al, 1996, Worth andBalls, 2004) and assists in its correct usage. Following the evaluation of molecular descriptors of the test and training set chemicals, an apparent difference in molecular weights was observed between the test and training set, indicating that a higher molecular weight range is present in the agrochemical AI test set compared to that seen in the training set.…”

Section: In Silico Evaluation -Mechanistic Chemistry and Physicochemical Property Domainsmentioning

confidence: 99%

Comparison of the predictive nature of the Genomic Allergen Rapid Detection (GARD) assay with mammalian assays in determining the skin sensitisation potential of agrochemical active ingredients

Masinja

Elliott

Modi

et al. 2021

Toxicology in Vitro

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Alternatives to mammalian testing are highly desirable to predict the skin sensitisation potential of agrochemical active ingredients (AI). The GARD assay, a stimulated, dendritic cell-like, cell line measuring genomic signatures, was evaluated using twelve AIs (seven sensitisers and five nonsensitisers) and the results compared with historical results from guinea pig or local lymph node assay (LLNA) studies. Initial GARD results suggested 11/12 AIs were sensitisers and six concurred with mammalian data. Conformal predictions changed one AI to a non-sensitiser. An AI identified as nonsensitising in the GARD assay was considered a potent sensitiser in the LLNA. In total 7/12 GARD results corresponded with mammalian data. AI chemistries might not be comparable to the GARD training set in terms of applicability domains. Whilst the GARD assay can replace mammalian tests for skin sensitisation evaluation for compounds including cosmetic ingredients, further work in agrochemical chemistries is needed for this assay to be a viable replacement to animal testing. The work conducted here is, however, considered exploratory research and the methodology needs further development to be validated for agrochemicals. Mammalian and other alternative assays for regulatory safety assessments of AIs must provide confidence to assign the appropriate classification for human health protection.

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“…Most of animalbased test methods never underwent formal validation according to internationally agreed criteria [35][36][37]; a firm conclusion on the sensitivity and specificity of these tests and their relevance for predicting adverse effects to humans can thus not be made. The bitter lesson of thalidomide has pointed to the need for predictive tests.…”

Section: Classical Approach To Reproductive Toxicity Assessmentmentioning

confidence: 99%

The Development of New Concepts for Assessing Reproductive Toxicity Applicable to Large Scale Toxicological Programmes

Bremer¹,

Pellizzer²,

Hoffmann³

et al. 2007

CPD

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Large scale toxicological testing programmes which are currently ongoing such as the new European chemical legislation REACH require the development of new integrated testing strategies rather than applying traditional testing schemes to thousands of chemicals. The current practice of requiring in vivo testing for every possible adverse effect endanger the success of these programmes due (i) to limited testing facilities and sufficient capacity of scientific/technical knowledge for reproductive toxicity; (ii) an unacceptable number of laboratory animals involved (iii) an intolerable number of chemicals classified as false positive. A key aspect of the implementation of new testing strategies is the determination of prevalence of reproductive toxicity in the universe of industrial chemicals. Prevalences are relevant in order to be aware on the expected rate of false classification during the toxicological testing and to implement appropriate measures for their avoidance. Furthermore, a detailed understanding on the subendpoints affected by reproductive toxicants and the underlying mechanisms will lead to more science based testing strategies integrating alternative methods without compromising the protection of consumers.

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The Principles of Validation and the ECVAM Validation Process

Cited by 15 publications

References 21 publications

Body Shape Questionnaire-34 (BSQ) and Functionality Appreciation Scale (FAS) - pertinent body image screening tools: Creation and validation of Polish language versions

Body Shape Questionnaire-34 (BSQ) and Functionality Appreciation Scale (FAS) - pertinent body image screening tools: Creation and validation of Polish language versions

Comparison of the predictive nature of the Genomic Allergen Rapid Detection (GARD) assay with mammalian assays in determining the skin sensitisation potential of agrochemical active ingredients

The Development of New Concepts for Assessing Reproductive Toxicity Applicable to Large Scale Toxicological Programmes

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