Details
| Original language | English |
|---|---|
| Pages (from-to) | 77-80 |
| Number of pages | 4 |
| Journal | ATLA Alternatives to Laboratory Animals |
| Volume | 31 |
| Issue number | SUPPL. 1 |
| Publication status | Published - Nov 2003 |
Abstract
Sample sizes given in regulatory guidelines are not based on statistical reasoning. However, from an ethical, scientific, and regulatory point of view, a mutagenicity experiment must have a reasonable chance of supporting the decision as to whether a result is negative or positive. Consequently, the sample size should be based on type I and type II errors, the underlying variability, and the specific size of a treatment effect. A two-stage adaptive interim analysis is presented, which permits an adaptive choice of sample size after an interim analysis of the data from the first stage. Because the sample size of the first stage is considered to be a minimum requirement, this stage can also be regarded as a pilot study.
Keywords
- Interim analysis, Mutagenicity assay, Proof of safety, Two-stage testing
ASJC Scopus subject areas
- Medicine(all)
- General Medicine
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In: ATLA Alternatives to Laboratory Animals, Vol. 31, No. SUPPL. 1, 11.2003, p. 77-80.
Research output: Contribution to journal › Review article › Research › peer review
}
TY - JOUR
T1 - Two-stage testing of safety
T2 - A statistical view
AU - Hauschke, Dieter
AU - Hothorn, Ludwig A.
PY - 2003/11
Y1 - 2003/11
N2 - Sample sizes given in regulatory guidelines are not based on statistical reasoning. However, from an ethical, scientific, and regulatory point of view, a mutagenicity experiment must have a reasonable chance of supporting the decision as to whether a result is negative or positive. Consequently, the sample size should be based on type I and type II errors, the underlying variability, and the specific size of a treatment effect. A two-stage adaptive interim analysis is presented, which permits an adaptive choice of sample size after an interim analysis of the data from the first stage. Because the sample size of the first stage is considered to be a minimum requirement, this stage can also be regarded as a pilot study.
AB - Sample sizes given in regulatory guidelines are not based on statistical reasoning. However, from an ethical, scientific, and regulatory point of view, a mutagenicity experiment must have a reasonable chance of supporting the decision as to whether a result is negative or positive. Consequently, the sample size should be based on type I and type II errors, the underlying variability, and the specific size of a treatment effect. A two-stage adaptive interim analysis is presented, which permits an adaptive choice of sample size after an interim analysis of the data from the first stage. Because the sample size of the first stage is considered to be a minimum requirement, this stage can also be regarded as a pilot study.
KW - Interim analysis
KW - Mutagenicity assay
KW - Proof of safety
KW - Two-stage testing
UR - http://www.scopus.com/inward/record.url?scp=0042697244&partnerID=8YFLogxK
U2 - 10.1177/026119290303101s05
DO - 10.1177/026119290303101s05
M3 - Review article
C2 - 15595902
AN - SCOPUS:0042697244
VL - 31
SP - 77
EP - 80
JO - ATLA Alternatives to Laboratory Animals
JF - ATLA Alternatives to Laboratory Animals
SN - 0261-1929
IS - SUPPL. 1
ER -