Collaborative Behavioral Teratology Study: statistical approach.

The design of the Collaborative Behavioral Teratology Study included six laboratories and two test compounds, d-amphetamine sulfate and methylmercuric chloride. For each lab-compound combination, there were four doses, four replicates (reps), four litters within each dose-rep combination, and eight pups per litter (four males and four females). Two males and two females per litter had early experience testing, the other pups in each litter were naive until day 21 of age. A repeated measures analysis of variance was used to analyze the data. The three major questions addressed were reliability, sensitivity, and effects of early testing experience. The question of litter or pup being the appropriate experimental unit also is discussed. An explanation of interactions and an example of sample size calculations are included.