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Biostatistical Assessment of Mutagenicity Studies by Including the Positive Control
Author(s) -
Hauschke Dieter,
SlacikErben Renate,
Hensen Sabrina,
Kaufmann Ronny
Publication year - 2005
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.200410082
Subject(s) - positive control , negative control , statistics , mathematics , relevance (law) , statistical analysis , statistical hypothesis testing , statistical significance , control (management) , significant difference , toxicology , econometrics , medicine , biology , computer science , artificial intelligence , traditional medicine , political science , law
Statistical analysis plays a fundamental part in the evaluation of mutagenicity experiments. However, a statistically significant or non‐significant test result without incorporating the biological relevance cannot be a valid scientific criterion for concluding a positive or negative effect of the underlying compound (Hauschke et al., 1997). The classification of an experiment as being negative or positive should be based also on the magnitude of the responses in the positive control. We address the problem of determining the maximum safe dose by incorporating a biologically meaningful threshold value, which is expressed as a fraction of the difference between positive and vehicle control. (© 2005 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)