Bioequivalence and Bioavailability Forum • OT: A major loss

OT: A major loss [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2019-02-14 01:24 (2692 d 00:14 ago) – Posting: # 19911
Views: 7,210

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] 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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Dabigatran EMA - product-specific guide nobody 2019-02-13 18:58
- 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