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Proof of Safety in Toxicology Based on the Ratio of Two Means for Normally Distributed Data
Author(s) -
Hauschke Dieter,
Kieser Meinhard,
Hothorn Ludwig A.
Publication year - 1999
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/(sici)1521-4036(199906)41:3<295::aid-bimj295>3.0.co;2-2
Subject(s) - sample size determination , toxicology , reliability engineering , computer science , population , statistics , mathematics , engineering , medicine , environmental health , biology
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.