3 period full repli­cate [RSABE / ABEL]

posted by Dr_Dan  – Germany, 2015-06-24 15:55 (3219 d 12:36 ago) – Posting: # 14974
Views: 31,481

Dear all
From a leading European regulatory authority I just recieved the information that a 3-period full replicate design (two sequences: T-R-T and R-T-R) for a bioequivalence study will not be accepted. The reason is that

for a full replicate design R as well as T need to be replicated and this is only possible with the res­pec­tive sequences (so TTRR etc.). A 3-period full replicate design would result only in two parallel sepa­rate groups (one which – apart from the integrated 2-period crossover– only get Test and the other only Reference); an evaluation would probably only possible as a general 2-period crossover study.

Please excuse the confusing explanation but the text set in italic is the verbal translation from what I received.
My interest is just of academic nature: What should one reply to this attitude?
Looking forward to your replies and to a fruitful discussion.
Kind regards

Edit: Category changed from Design Issues. I think this category fits better – especially if one is inter­ested in reference-scaling. [Helmut]

Kind regards and have a nice day

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