Piet Hoogkamer, Principal Scientist, Abbott Established Pharmaceuticals
Sven Daniel Schmitz, Senior Scientist, Abbott Established Pharmaceuticals
Several regulatory rules for conducting a comparative dissolution study in support of a biowaiver have been published. It is all about comparing two multivariate data sets, where the difference in mean should be acceptable. For 25 years, there has been much debate on what to do when the observed data are 'highly' variable. Many approaches have been published, such as model-free or model-based methods. With JMP® 17, some functionality has become available, including bootstrapping. This presentation will give an overview of proposed methods and how JMP can be used. The new JMP 17 functionality will be compared to what authorities require, along with guidance for possible extensions of the current JMP functionality.
