Bioequivalence and Bioavailability Forum

Dear All,

Regarding the Draft Guidance on Paliperidone Palmitate Paliperidone

It states that Both sites of injection (gluteal and deltoid) should be included in the study design for adequate site representation to support the results of the study

That mean, there gonna be an injection site effect in the anova model , sequence*site and subject(Sequence*site ) effects ?

Also regarding sample size for such design suppose a crossover design

The published data suggest an inter-subject variability of 40 - 50 % and no published data on Intra subject variability Xeplion Assessment report
In most cases the inter-subject > intra subject,thus if falsely assuming that the inter = intra That the study gonna be over powered ? how about ethical point and assessor point ?
Or it's more realistic to assume intra = 60 % of the inter variability?
Also about sample size estimation ,will it differ that the study patients gonna be divided into Two groups according to the site of injection ?

Thanks in advance

Best Regards