Evaluation of reproductive toxicity assays
5.1 The statistical problems
The appropriate statistical evaluation of reproduction/development studies, particularly multi-generation assays , is rather complex. The most important feature of reproductive assays is the correlation between the litter mates within a dam. The simpler teratogenicity study will be used here for demonstration purposes, where pregnant females are treated with the test compound in a randomized design including several dose groups and a negative control. At a certain stage of gestation the females are sacrified and several reproductive parameters such as number of pre-implantations, implantations, alive or dead pups, malformations, and pup weights are estimated ...