Pharmaceutical Statistics Using SAS

5.2. Key Statistical Aspects of Toxicology Studies

The key statistical aspects of the design and analysis of toxicology studies to be discussed are randomization, power evaluation and data analysis.

5.2.1. Randomization

Since proper randomization is the foundation of valid statistical inference, this chapter starts with the randomization methods for two commonly used designs in toxicology, namely, the parallel design and Latin square design.

Parallel designs include studies with one factor, two factors, one-factor with repeated measurements, and more. In a parallel design, separate groups of animals are assigned to combinations of factor levels. For example, in a one-factor design with four dose groups, there would be four different groups ...