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155 results on '"Meek, M.E."'

1. Towards a qAOP framework for predictive toxicology - Linking data to decisions

Author

Paini, Alicia, Campia, Ivana, Cronin, Mark T.D., Asturiol, David, Ceriani, Lidia, Exner, Thomas E., Gao, Wang, Gomes, Caroline, Kruisselbrink, Johannes, Martens, Marvin, Meek, M.E. Bette, Pamies, David, Pletz, Julia, Scholz, Stefan, Schüttler, Andreas, Spînu, Nicoleta, Villeneuve, Daniel L., Wittwehr, Clemens, Worth, Andrew, and Luijten, Mirjam

Published
2022
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12. Problem Formulation for EFSA Scientific Assessments.

Author

Paoli, Greg, Momoli, Franco, Tyshenko, Michael G, Meek, M.E. Bette, and Krewski, Daniel

Subjects
EVALUATION
Abstract

This report addresses the problem formulation step of scientific assessments to support the European Food Safety Authority (EFSA) in the development of guidance. The current report is comprised of a review of published literature on approaches for problem formulation, an environmental scan of two years of scientific assessments published in the EFSA Journal, classification of each publication as to its questions and sub‐questions, and a proposed framework and drafted handbook of recommendations to guide problem formulation. Over 700 EFSA publications were reviewed to identify scientific assessment activities, questions, and sub‐questions. A framework was developed to: 1) translate the mandate into assessment questions; 2) define the sub‐questions of each assessment and their relationship, optionally including a conceptual model; and 3) select the approach to take in designing the methods of the protocol for the assessment. The framework and guidance for problem formulation describe the role of literature scans, question formulation, relationships among sub‐questions, and screening and prioritizing sub‐questions. The report includes proposed cross‐cutting language with a common set of terms to promote understanding and application across diverse EFSA domains. For question formulation, the acronym APRIO was proposed, referring to A(gent), P(athway), R(eceptor), I(ntervention), and O(utput) as variously essential elements of all EFSA questions and sub‐questions. [ABSTRACT FROM AUTHOR]

Published
2022
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14. New developments in the evolution and application of the WHO/IPCS framework on mode of action/species concordance analysis+

Author

Meek, M.E., Boobis, A., Cote, I., Dellarco, V., Fotakis, G., Munn, S., Seed, J., and Vickers, C.

Subjects
human relevance framework, key events, weight of evidence approach, World Health Organization, cellular response, Risk Assessment, Article, mode of action, adverse outcome pathway, molecular target, tissue response, modified Bradford Hill considerations, species concordance analysis, Models, Animal, Toxicity Tests, Animals, Humans
Abstract

The World Health Organization/International Programme on Chemical Safety mode of action/human relevance framework has been updated to reflect the experience acquired in its application and extend its utility to emerging areas in toxicity testing and non-testing methods. The underlying principles have not changed, but the framework's scope has been extended to enable integration of information at different levels of biological organization and reflect evolving experience in a much broader range of potential applications. Mode of action/species concordance analysis can also inform hypothesis-based data generation and research priorities in support of risk assessment. The modified framework is incorporated within a roadmap, with feedback loops encouraging continuous refinement of fit-for-purpose testing strategies and risk assessment. Important in this construct is consideration of dose-response relationships and species concordance analysis in weight of evidence. The modified Bradford Hill considerations have been updated and additionally articulated to reflect increasing experience in application for cases where the toxicological outcome of chemical exposure is known. The modified framework can be used as originally intended, where the toxicological effects of chemical exposure are known, or in hypothesizing effects resulting from chemical exposure, using information on putative key events in established modes of action from appropriate in vitro or in silico systems and other lines of evidence. This modified mode of action framework and accompanying roadmap and case examples are expected to contribute to improving transparency in explicitly addressing weight of evidence considerations in mode of action/species concordance analysis based on both conventional data sources and evolving methods.

Published
2013

20. Using mode of action information to improve regulatory decision-making: An ECETOC/ILSI RF/HESI workshop overview

Author

Carmichael, Neil, primary, Bausen, Melanie, additional, Boobis, Alan R., additional, Cohen, Samuel M., additional, Embry, Michelle, additional, Fruijtier-Pölloth, Claudia, additional, Greim, Helmut, additional, Lewis, Richard, additional, (Bette) Meek, M.E., additional, Mellor, Howard, additional, Vickers, Carolyn, additional, and Doe, John, additional

Published
2011
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22. Risk Assessment Practice for Essential Metals

Author

Meek, M.E. (Bette), primary, Levy, Leonard S., additional, Beck, Barbara D., additional, Danzeisen, Ruth, additional, Donohue, Joyce M., additional, Arnold, Ian M. F., additional, and Krewski, Daniel, additional

Published
2010
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23. Preface

Author

Meek, M.E. (Bette), primary, McArdle, Harry J., additional, and Bédard, Daniel, additional

Published
2010
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