Factorial designs in pharmaceutical stability studies.

An approach to analyzing and interpreting kinetic data from stability studies using factorial designs is presented. This may be useful for screening purposes or as an aid in identifying significant effects in complex systems. A typical 2n factorial experiment is discussed, and methods of variance estimation and statistical testing are presented. An example of simulated data is used to demonstrate how typical results may be analyzed, as well as the potential and limitations of this design in interpretation and construction of kinetic models.