BE study stratified per body weight group [General Statistics]
additionally to what Helmut and Detlew wrote:
❝ 1) Can the BE assessment be based on all data combined or does this require a separate analysis per body weight stratum
- for subjects with weight <z kg,
- for subjects with weight >z kg.
Pro: standard evaluation (2x)
Con: approx. double number of subjects required (than in option 2))
❝ 2) If a combined assessment is the way to go how should the model look like ...
Maybe:
Period (1 or 2 or 3)
Sequence (six options acc. to Williams’ design)
BWS (Body Weight Strata, values 1 or 2)
Subject (nested within BWS*Sequence) (sequence and BWS are between-subject factors)
BWS*Sequence
Treatment (nested within BWS) (same situation as Period (nested within Group) in FDA suggested model for studies in multiple groups ... periods differ for different groups, here treatments differ for different BWS)
Possible option would be to use dose correction and then evaluation using the standard model.
Though I realized that there is the same dose correction for T1,T2,R in the half of the subjects and similarly in the second half ... so the ratios will stay unchanged regardless the correction.
Pro: Less subjects required in total (if you are not interested in separate analysis)
Con: model

Best regards,
zizou
Complete thread:
- BE study stratified per body weight group martin 2018-06-08 09:15 [General Statistics]
- BE study stratified per body weight group Helmut 2018-06-08 11:04
- BE study stratified per body weight group d_labes 2018-06-08 17:04
- BE study stratified per body weight groupzizou 2018-06-08 21:11