Quick Q for my clarification [Design Issues]

posted by ElMaestro  – Denmark, 2012-11-06 13:09 (4622 d 18:09 ago) – Posting: # 9509
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Hi Martin,

why would it be an aim to replicate administration of the test product? Save a period? I ask because I think most sponsors only wish to replicate due to scaling options, and then only replication of the ref. comes into play. Is your situation somehow demanding knowledge of intra-subject variability for all formulations?

Anyways, from a theoretical standpoint I guess the higher order of carry-over is interesting but in my experience agencies aren't too concerned. After all, there are many more obvious assumptions and shortcuts in play when we do BE; mandatory parametric statistics as one example, neglection of nuisance effects as a prominent other example. So in practice carry-over is just something that is of practical concern to you when the girlfriend has spent 9 hours shopping and needs assistance to get 17 bags of clothes transferred to your car in the parking lot.
If your test subjects have long tails and eat cheese then I wouldn't know how it would be assessed, though.

Pass or fail!
ElMaestro

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