Bioequivalence and Bioavailability Forum

OT: A major loss [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2019-02-14 01:24 (2222 d 06:00 ago) – Posting: # 19911
Views: 5,597

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. Open access.

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.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• Dabigatran EMA - product-specific guide nobody 2019-02-13 18:58 [Regulatives / Guidelines] 
  • Dabigatran EMA - product-specific guide ElMaestro 2019-02-13 22:59
    • OT: A major lossHelmut 2019-02-14 00:24
      • OT: A major loss nobody 2019-02-14 09:31
        • OT: A major loss Helmut 2019-02-14 11:37
          • OT: A major loss nobody 2019-02-14 13:40
  • Dabigatran EMA - product-specific guide Helmut 2019-02-14 12:12
    • Dabigatran EMA - product-specific guide nobody 2019-02-14 13:34
      • Dabigatran EMA - product-specific guide Helmut 2019-02-14 13:52
        • Dabigatran EMA - product-specific guide nobody 2019-02-14 15:01