a Ahmad


Hi Everyone,


I have a question regarding generating Trial element domain for fully replicate bioequivalence studies.

In the fully replicate bioequivalence studies, After randomization, healthy subjects will take a single dose from the test product ( drug A), then after first washout period, they will take a single dose of the reference product (Drug B), then they will take single dose of test product again ( drug A). And after the third washout period they will take reference product again (Drug B). Study will be 2 Sequence design (ABAB or BABA).

I tried to generate domain for this study as per attached document. but I think there is something wrong since the generated trial element will be the same if the study is not fully replicate (i.e. AB or BA ).

Is there anyone faced this issue before or have explanation how to generate trial element for this type of the studies.



Attached Files

Forums: SDTM

j Jozef
on September 27, 2022

I think it is a very good idea to also post this question on the LinkedIn SDTM discussion forum at https://www.linkedin.com/groups/2758697/ ("only" 3243 members), as this question has little to do with P21 validation, and all the major SDTM "gurus" are on that LinkedIn forum.
Also, please don't post MS-Word attachments, better is to use PDF.

a Ahmad
on September 27, 2022

Thank you Jozef

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