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Group Effect in Full Replicate Design [RSABE / ABEL]

posted by GM - India, 2018-09-12 07:17  - Posting: # 19267
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Dear All,

Hope all are doing well.

We are conducting a BE study of Highly variable drug in patient population. This study will be conducted in 3 groups, which are seperated by one month from each other. There is no clarity in the guidance to check the group effect for this design.

Our doubt is, whether the group effect should be checked in the full replicate design or not?

If so, what are the fixed/random effets need to be checked in RSABE and ABE?

Kindly explain.

Best Regards,
GM

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