Bioequivalence and Bioavailability Forum

Hi all,

couldn't help but had to start thinking about the implementation of this.

Now directly for the tricky stuff:

First:
We start out with 3 treatments at stage 1. This means that at stage 1 we have 6 different sequences.
After stage 1 we take a formulation and put it into the trash can. Stage 2 therefore has 2 treatments and thus also 2 sequences. This implies that we have to speak of sequence in stage rather than just sequence.
Does anyone agree?

Second:
The following terms should be evaluated:

• Subject (no I am not nesting them in something because I code them uniquely)
  
• Sequence in Stage (with nesting; we could also just give them factor levels like 1,2,3,4,5,6,7,8 and observe that 1..6 apply to stage 1 and 7..8 apply in stage 2.
  
• Period in stage (with nesting; 1..3 at stage 1 and 1..2 in stage 2. We could also nominate them 1..5)
  
• Treatment
  
• Stage

And Sequence in its own right would be a completely irrelevant term - EMAs Q&A is not applicable here.

Does anyone agree?

Third:
Here's a dataset
- the owner of Fuglsang Pharma (a miserable person of generally dubious character) kindly allowed me to upload it there
You can save it somewhere and open it in R like this:

A=read.table("testout.txt", header=T) # reads the data

B=subset(A, Trt!=2) ## we now exclude treatment 2; we only wish to look at treatment 1 vs 3

M1=lm(B$lnPK~0+
    as.factor(B$Trt)
   +as.factor(B$Seq):as.factor(B$Stg)
   +as.factor(B$Subj)
   +as.factor(B$Per):as.factor(B$Stg)
   +as.factor(B$Stg))

anova(M1)
# Quite nice; we just need to deal with three terms,
# one of them nested before
# everything else is uniquely determined. 

Anyone agrees?
(I guess I will receive a beating for this)