Statistical evaluation of toxicological bioassays - a review

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Hothorn, Ludwig A.: Statistical evaluation of toxicological bioassays - a review. In: Toxicology Research 3 (2014), Nr. 6, S. 418-432. DOI:

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Sum total of downloads: 150

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.
License of this version: CC BY-NC 3.0 Unported
Document Type: article
Publishing status: publishedVersion
Issue Date: 2014
Appears in Collections:Naturwissenschaftliche Fakultät

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downloads by country:

pos. country downloads
total perc.
1 image of flag of Germany Germany 123 82.00%
2 image of flag of United States United States 8 5.33%
3 image of flag of Canada Canada 3 2.00%
4 image of flag of Japan Japan 2 1.33%
5 image of flag of China China 2 1.33%
6 image of flag of Switzerland Switzerland 2 1.33%
7 image of flag of Brazil Brazil 2 1.33%
8 image of flag of Russian Federation Russian Federation 1 0.67%
9 image of flag of Indonesia Indonesia 1 0.67%
10 image of flag of United Kingdom United Kingdom 1 0.67%
    other countries 5 3.33%

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