Bioequivalence and Bioavailability Forum

Sawasdee all.
Thank you for all comments.
I'm sorry, I think my response to my topic is static. So I'm back late.

Well, according to Thai FDA document on group effect.
I think it used the word "SHOULD" in the statements.
I agree with the document that
1) the number of groups should be minimized
2) the number of subjects in each group should be equal
3) the washout period should be the same
4) the period time in each group should be as close as possible

I think the investigator should try to follow such design, however, some deviation can be allowed according to the protocol.

It should not run according to the subject's convenience or investigator's or facitility's convenience, right?

What do you think if suppose that a facility can deal with a maximum of 12 subjects.
They plan for 40 subjects study.
A minimum washout period was set in the protocol, let's say at least 5 half-lives.

If the investigator set the number of groups, number of subjects per group, washout period of each subjects according to subject's convenience. It can end up with 8 groups, some group might have 2 subjects, each subjects can have different washout time. What do you think about this study?

I agree with Mr. Boonchai for group effect, it may not need for combining the result.
But I would open for more comments on this group effect.


Sarawut