Details
| Original language | English |
|---|---|
| Pages (from-to) | 295-304 |
| Number of pages | 10 |
| Journal | Biometrical journal |
| Volume | 41 |
| Issue number | 3 |
| Publication status | Published - 26 May 1999 |
Abstract
The aim of toxicology testing is the safety assessment of a substance such as a new pharmaceutical compound or a pesticide relative to a vehicle or negative control. This paper is concerned with the direct safety approach when safety is expressed in terms of the ratio of population means and when the toxicological endpoint is normally distributed. The methodology for power and sample size calculation is derived for the parallel group design and results are presented for various situations.
Keywords
- Proof of safety, Ratio of means, Sample size
ASJC Scopus subject areas
- Mathematics(all)
- Statistics and Probability
- Decision Sciences(all)
- Statistics, Probability and Uncertainty
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In: Biometrical journal, Vol. 41, No. 3, 26.05.1999, p. 295-304.
Research output: Contribution to journal › Article › Research › peer review
}
TY - JOUR
T1 - Proof of safety in toxicology based on the ratio of two means for normally distributed data
AU - Hauschke, Dieter
AU - Kieser, Meinhard
AU - Hothorn, Ludwig A.
PY - 1999/5/26
Y1 - 1999/5/26
N2 - The aim of toxicology testing is the safety assessment of a substance such as a new pharmaceutical compound or a pesticide relative to a vehicle or negative control. This paper is concerned with the direct safety approach when safety is expressed in terms of the ratio of population means and when the toxicological endpoint is normally distributed. The methodology for power and sample size calculation is derived for the parallel group design and results are presented for various situations.
AB - The aim of toxicology testing is the safety assessment of a substance such as a new pharmaceutical compound or a pesticide relative to a vehicle or negative control. This paper is concerned with the direct safety approach when safety is expressed in terms of the ratio of population means and when the toxicological endpoint is normally distributed. The methodology for power and sample size calculation is derived for the parallel group design and results are presented for various situations.
KW - Proof of safety
KW - Ratio of means
KW - Sample size
UR - http://www.scopus.com/inward/record.url?scp=0033467715&partnerID=8YFLogxK
U2 - 10.1002/(SICI)1521-4036(199906)41:3<295::AID-BIMJ295>3.0.CO;2-2
DO - 10.1002/(SICI)1521-4036(199906)41:3<295::AID-BIMJ295>3.0.CO;2-2
M3 - Article
AN - SCOPUS:0033467715
VL - 41
SP - 295
EP - 304
JO - Biometrical journal
JF - Biometrical journal
SN - 0323-3847
IS - 3
ER -