Statistical evaluation of toxicological bioassays - a review

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dc.identifier.uri Hothorn, Ludwig A. 2015-10-23T13:51:36Z 2015-10-23T13:51:36Z 2014
dc.identifier.citation Hothorn, Ludwig A.: Statistical evaluation of toxicological bioassays - a review. In: Toxicology Research 3 (2014), Nr. 6, S. 418-432. DOI:
dc.description.abstract The basic conclusions in almost all reports on new drug applications and in all publications in toxicology are based on statistical methods. However, serious contradictions exist in practice: designs with small samples sizes but use of asymptotic methods (i.e. constructed for larger sample sizes), statistically significant findings without biological relevance (and vice versa), proof of hazard vs. proof of safety, testing (e.g. no observed effect level) vs. estimation (e.g. benchmark dose), available statistical theory vs. related user-friendly software. In this review the biostatistical developments since about the year 2000 onwards are discussed, mainly structured for repeated-dose studies, mutagenicity, carcinogenicity, reproductive and ecotoxicological assays. A critical discussion is included on the unnecessarily conservative evaluation proposed in guidelines, the inadequate but almost always used proof of hazard approach, and the limitation of data-dependent decision-tree approaches. eng
dc.language.iso eng
dc.publisher Cambridge : Royal Society of Chemistry
dc.relation.ispartofseries Toxicology Research 3 (2014), Nr. 6
dc.rights CC BY-NC 3.0 Unported
dc.subject simultaneous confidence-intervals eng
dc.subject exchangeable binary data eng
dc.subject historical control data eng
dc.subject tumor-incidence rates eng
dc.subject benchmark dose estimation eng
dc.subject quantal-response test eng
dc.subject subunit-specific outcomes eng
dc.subject sprague-dawley rats eng
dc.subject lymph-node assay eng
dc.subject poly-k test eng
dc.subject.ddc 540 | Chemie ger
dc.title Statistical evaluation of toxicological bioassays - a review eng
dc.type article
dc.type Text
dc.relation.essn 2045-4538
dc.relation.issn 2045-452X
dc.bibliographicCitation.issue 6
dc.bibliographicCitation.volume 3
dc.description.version publishedVersion
tib.accessRights frei zug�nglich

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