Extremely small sample size in some toxicity studies: an example from the rabbit eye irritation test.
The conventional sample-size equations based on either the precision of estimation or the power of testing a hypothesis may not be appropriate to determine sample size for a "diagnostic" testing problem, such as the eye irritant Draize test. When the animals' responses to chemical compounds are relatively uniform and extreme and the objective is to classify a compound as either irritant or nonirritant, the test using just two or three animals may be adequate.
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Division of Mathematics, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street SW, Washington, DC 20204, USA.
D000818:Animals; D001499:Bayes Theorem; D003657:Decision Making; D005123:Eye / Q000187:drug effects*; D005128:Eye Diseases / Q000139:chemically induced*; D005188:False Negative Reactions; D005189:False Positive Reactions; D006801:Humans; D011050:Policy Making; D011634:Public Health; D011817:Rabbits; D015203:Reproducibility of Results; D012107:Research Design; D018570:Risk Assessment; D018401:Sample Size; D018675:Toxicity Tests