Effect group in full replicate Bioequivalence [Study Per­for­mance]

posted by Laura Carreiras – Portugal, 2022-05-11 15:11 (322 d 13:08 ago) – Posting: # 22969
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In a in a bioequivalence study with a full replicate design conducted in more than one group, how shall the group participants be separated/divided?

For example,

Initially we have 3 groups but because of some constraints the washouts for a few participants had to be extended.

The participants will be added to the groups accordingly with the administration date of the first period (even if the other periods can have a different administration date) or the groups shall be formed accordingly with the date of administration of all the periods (for each group all the administration date of the 4 periods has to be the same)?

I hope I was clear.

Thank you for the help.

Edit: Category changed; see also this post #1[Helmut]

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