Environmental and Ecological Statistics

, Volume 7, Issue 1, pp 27–42 | Cite as

Dose-response relationships in mutagenicity assays including an appropriate positive control group: a multiple testing approach

  • Ludwig A. Hothorn
  • Makoto Hayashi
  • Dirk Seidel


The objective of mutagenicity assays in regulatory toxicology is the decision on non-mutagenicity or mutagenicity. An inherent problem of statistical tests is the possibility of false decisions, i.e., a mutagenic substance will be falsely labeled as non-mutagenic or a non-mutagenic substance will be falsely labeled as mutagenic. These probabilities of false negative (consumer's risk=type II error) and/or false positive decision (producer's risk=type I error) can be limited by using suitable testing procedures as well as a design including an appropriate positive control. Using the proof of hazard concept the well-known many-to-one procedures with total order restriction for increasing effect differences are used, while using the proof of safety concept procedures on equivalence with total order restriction are discussed. Both approaches are demonstrated on a real data example.

dose-response analysis positive control mutagenicity studies 


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Copyright information

© Kluwer Academic Publishers 2000

Authors and Affiliations

  • Ludwig A. Hothorn
    • 1
  • Makoto Hayashi
    • 2
  • Dirk Seidel
    • 1
  1. 1.Department of BioinformaticsUniversity of HannoverHannoverGermany
  2. 2.National Institute of Health SciencesTokyoJapan

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