Bioequivalence and Bioavailability Forum

Hello Angus,

❝ In the Bio equivalence output in Phoenix WinNonlin "Partial tests" are given and so are "sequential tests" in tabs. The tests are described in the Users manual (see link) and below material from the manual. I am wondering which tab one would use in for regulatory report or would one submit both?

Welcome to the strange world of type III sums of squares (your partial tests). Invented by SAS, not widely agreed but widely used implicitly since this is what SAS just does. The sequential tests are called type I.

The residual and treatment effect differences will be the same for both a type I and type III anova, since both are based on the same model. It is the model that determines the residual, not the anova. The only difference will be the SS and MS values, and hence F-tests and p-values, for the fixed factors. You will only see a difference in imbalanced datasets (e.g. when the number of subjects in RT and TR differ).

Since the residual and the treatment effect differences are the same for type I and type III, the confidence intervals will be invariant and you can submit one of them or both as you please. It is quite common to submit both (I speculate this is due to SAS habits?).

I have no idea why Pharsight thinks any user needs some info relating to QR factorisation when trying to figure out what type III tests are. The type III tests are done by comparing the grand residual to the residual of a model without the factor for which we are testing. That's all there is to it (although sequence is a little tricky due to the crossover but that's a story for another day).