Frameworks for evaluation and integration of data in regulatory evaluations: The need for excellence in regulatory toxicology

Following a number of published expressions of concern about the reliability of experimental science and the implications of non-reproducibility for regulatory toxicology, the European Risk Forum undertook to consider what practises might improve the basis on which regulatory decisions might be made...

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Main Author: Colin Berry
Format: Article
Language:English
Published: SAGE Publishing 2020-10-01
Series:Toxicology Research and Application
Online Access:https://doi.org/10.1177/2397847320951377
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spelling doaj-bd93a7ef11d14813ace095b000d325592020-11-25T03:52:36ZengSAGE PublishingToxicology Research and Application2397-84732020-10-01410.1177/2397847320951377Frameworks for evaluation and integration of data in regulatory evaluations: The need for excellence in regulatory toxicologyColin Berry0 Professor Emeritus of Pathology, , London, UKFollowing a number of published expressions of concern about the reliability of experimental science and the implications of non-reproducibility for regulatory toxicology, the European Risk Forum undertook to consider what practises might improve the basis on which regulatory decisions might be made. Guidelines which may be useful in assessments are presented. The document acknowledges the value of the experimental standards used in most regulatory studies but indicates how these may fail to provide the ‘best outcome’ and how imperfect studies based on outdated views of pathophysiology of disease in H. Sapiens may offer little of predictive value.https://doi.org/10.1177/2397847320951377
collection DOAJ
language English
format Article
sources DOAJ
author Colin Berry
spellingShingle Colin Berry
Frameworks for evaluation and integration of data in regulatory evaluations: The need for excellence in regulatory toxicology
Toxicology Research and Application
author_facet Colin Berry
author_sort Colin Berry
title Frameworks for evaluation and integration of data in regulatory evaluations: The need for excellence in regulatory toxicology
title_short Frameworks for evaluation and integration of data in regulatory evaluations: The need for excellence in regulatory toxicology
title_full Frameworks for evaluation and integration of data in regulatory evaluations: The need for excellence in regulatory toxicology
title_fullStr Frameworks for evaluation and integration of data in regulatory evaluations: The need for excellence in regulatory toxicology
title_full_unstemmed Frameworks for evaluation and integration of data in regulatory evaluations: The need for excellence in regulatory toxicology
title_sort frameworks for evaluation and integration of data in regulatory evaluations: the need for excellence in regulatory toxicology
publisher SAGE Publishing
series Toxicology Research and Application
issn 2397-8473
publishDate 2020-10-01
description Following a number of published expressions of concern about the reliability of experimental science and the implications of non-reproducibility for regulatory toxicology, the European Risk Forum undertook to consider what practises might improve the basis on which regulatory decisions might be made. Guidelines which may be useful in assessments are presented. The document acknowledges the value of the experimental standards used in most regulatory studies but indicates how these may fail to provide the ‘best outcome’ and how imperfect studies based on outdated views of pathophysiology of disease in H. Sapiens may offer little of predictive value.
url https://doi.org/10.1177/2397847320951377
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