Validation of alternative methods for toxicity testing

Bruner, Leon H.; Carr, G.J.; Chamberlain, M.; Curren, Rodger

doi:10.1016/0887-2333(96)00028-8

Cited by 78 publications

(50 citation statements)

References 32 publications

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“…In fact, prior to undertaking a validation study, data for a test method's characteristics, advantages, limitations, and transferability among qualified laboratories should be available and confirmed in an assessment of a protocol's readiness for validation. The validation program itself demonstrates that the protocol provides reproducible results and quantifies intra-and interlaboratory variation over time (Balls et al, 1990 andBruner et al, 1996a;Curren et al, 1995;ICCVAM, 1997;OECD, 1996OECD, , 1998b). An essential aspect of the validation process is to demonstrate that the protocol yields information that can be used by toxicologists and regulators to make correct predictions of toxic hazard and safety.…”

Section: Introductionmentioning

confidence: 97%

Critical Review and Evaluation of the Uterotrophic Bioassay for the Identification of Possible Estrogen Agonists and Antagonists: In Support of the Validation of the OECD Uterotrophic Protocols for the Laboratory Rodent

Owens

Ashby

2002

Critical Reviews in Toxicology

110

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A current issue for regulatory agencies is endocrine-related modes of action such as those mediated by the estrogen, androgen, and thyroid nuclear receptors. At the national and international levels, the consensus recommendation for the assessment of such modes of action is a tiered series of in vitro and in vivo protocols. The tiered framework begins with screens for structural alerts and then moves to rapid, mechanistic in vitro screening assays, and then to in vivo screening bioassays. The objective of these screens is to identify substances that may warrant testing for endocrine-mediated adverse effects. The final framework tier as needed is to test these substances in long-term bioassays for adverse endocrine-mediated reproductive and/or developmental effects. The subject of this review, the rodent uterotrophic bioassay, is intended to be a rapid in vivo screening bioassay for possible estrogen agonists and based on the response of the estrogen-sensitive uterus. The central metric of bioassay is a statistically significant increase in the weight of the uterus after 3 consecutive days of test substance administration. The extensive background literature is summarized in this review on the mode of action underlying the bioassay and the uterine response to estrogens. The review includes the bioassay's history of development and how its employment has changed and evolved over time. The review describes two major uterotrophic bioassay versions, the intact, immature female and the mature, ovariectomized female, and the protocol factors likely to influence relevance, reproducibility, and reliability of bioassay. The emphasis of the review is the ability of the uterotrophic bioassay to identify the substances of current interest: weak estrogen agonists with binding affinities relative to the natural 17beta-estradiol in the log 0 to log -3 range. Using selected model substances having RBAs in this target range, the bioassay's performance in a hierarchical, tiered approach is evaluated, including the predictive capability of the uterotrophic bioassay based on available reproductive and developmental testing data. The review concludes that the uterotrophic bioassay is reliable and can identify substances that may act via an estrogen-mode of action, supporting the validity of the uterotrophic bioassay and its regulatory use as an in vivo mechanistic screening bioassay for estrogen agonists and antagonists.

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Section: Introductionmentioning

confidence: 97%

Critical Review and Evaluation of the Uterotrophic Bioassay for the Identification of Possible Estrogen Agonists and Antagonists: In Support of the Validation of the OECD Uterotrophic Protocols for the Laboratory Rodent

Owens

Ashby

2002

Critical Reviews in Toxicology

110

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“…На данный момент в мире разработано множе-ство методик, направленных на оценку параметров, характеризующих биосовместимость материалов медицинского назначения как in vitro, так и in vivo (рисунок 2) [11,12]. Однако использование живот-ных моделей для рутинной оценки токсичности и биосовместимости материалов в настоящее вре-мя имеет большое количество ограничений.…”

Section: рисунок 2 том 4 №1 / 2017unclassified

Approaches to Biomaterials Testing According to Modern Biocompatibility Paradigm

Викнянщук¹,

Mishanin²,

Tverdokhlebov³

et al. 2017

Transl. med. (Print)

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“…Reliability is based on the establishment of test result reproducibility within and between laboratories and over time. Relevance is referred to the scientific significance and usefulness of results from an alternative method for a particular evaluation [11]. In Table 2, are listed in vitro systems that are currently being used, that range from relatively simple subcellular fractions, primary culture and cell lines up to 3D organotypic cultures [12].…”

Section: In Vitro Evaluation Of Cytotoxicitymentioning

confidence: 99%

Perspectives on:In Vitro Evaluation of Biomedical Polymers

Chiellini

2006

Journal of Bioactive and Compatible Polymers

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Recently polymeric materials have gained tremendous attention in a wide variety of applications spanning from electronics to environmental and biomedical fields. In this paper, current in vitro methods for polymers biocompatibility assessment are reviewed in combination with new concepts and techniques that appear promising for the development and improvement of in vitro methods with the purpose of reducing animal experimentation. The utilization of medical devices, for example, has always been subordinate to the assessment of their biocompatibility. This aspect, as well as the methods for evaluating biocompatibility have changed over the years as a result of new developments in cell biology that have revolutionized in vitro techniques for assaying polymeric materials for bioapplications.

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Validation of alternative methods for toxicity testing

Cited by 78 publications

References 32 publications

Critical Review and Evaluation of the Uterotrophic Bioassay for the Identification of Possible Estrogen Agonists and Antagonists: In Support of the Validation of the OECD Uterotrophic Protocols for the Laboratory Rodent

Critical Review and Evaluation of the Uterotrophic Bioassay for the Identification of Possible Estrogen Agonists and Antagonists: In Support of the Validation of the OECD Uterotrophic Protocols for the Laboratory Rodent

Approaches to Biomaterials Testing According to Modern Biocompatibility Paradigm

Perspectives on:In Vitro Evaluation of Biomedical Polymers

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