Deficiencies [Power / Sample Size]

posted by Relaxation  – Germany, 2018-02-02 20:41 (2326 d 09:20 ago) – Posting: # 18334
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❝ ❝ But seriously, why should testing alternatives in one study require a punishment and testing in seperate studies not. Because I pay my fee in doubled overhead study costs? Or because I don't have to tell anybody of the "other study" during application :confused:?


❝ IMHO, you have to submit the study’s synopsis.


Hello Helmut.

That was what I thought myself (and would also argue in favour of by gut feeling). But at least in the EU I think we are asked to submit these for the pilot studies conducted with the formulation you apply for. As far as I remember, it is also asked for synopses from other studies during formulation development, but my guess would be that there might be a grey area in the discussion, whether a study conducted with Alternative 1 would be part of the development of Alternative 2.
I personally would argue in favour of "full disclosure", but I generally :blahblah: a lot anyway.

P.S.: I looked it up in the BE-GL: all relevant studies ... comparing the formulation applied for (i.e. same composition and manufacturing process) with a reference medicinal product marketed in the EU.
Would apply to the "tablet vs. reference and capsule vs. reference" example brough up earlier, wouldn't it? Two shots.

Best regards and a nice weekend to everybody,

Relaxation.

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