TY - JOUR
T1 - Dose-response relationships in mutagenicity assays including an appropriate positive control group
T2 - A multiple testing approach
AU - Hothorn, Ludwig A.
AU - Hayashi, Makoto
AU - Seidel, Dirk
PY - 2000/3
Y1 - 2000/3
N2 - 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.
AB - 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.
KW - Dose-response analysis
KW - Mutagenicity studies
KW - Positive control
UR - http://www.scopus.com/inward/record.url?scp=0034046189&partnerID=8YFLogxK
U2 - 10.1023/A:1009654728475
DO - 10.1023/A:1009654728475
M3 - Article
AN - SCOPUS:0034046189
VL - 7
SP - 27
EP - 42
JO - Environmental and Ecological Statistics
JF - Environmental and Ecological Statistics
SN - 1352-8505
IS - 1
ER -