Bioequivalence and Bioavailability Forum 05:34 CET

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OT: A major loss [Regulatives / Guidelines]

posted by Helmut Homepage - Vienna, Austria, 2019-02-14 00:24  - Posting: # 19911
Views: 296

[image][image]Hi ElMaestro & nobody,

too bad that the Journal of Negative Results in Bio­medicine ceased to be published.

I like (seriously!) this one:

Hammami MM, Yusuf A, Shire FS, Hussein R, Al-Swayeh R. Does the placebo effect modulate drug bio­avail­ability? Randomized cross-over studies of three drugs. J Negat Results Biomed. 2017;16(1):10. doi:10.1186/s12952-017-0075-2. [image] free resource.

I’ll send it to my friends at HC stating in the guidance Section 2.4.2:

To avoid study bias [sic], comparative bioavailability studies should be conducted in such a way that the subjects are not aware of which product (test or reference) is being administered.


Cheers,
Helmut Schütz
[image]

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