Bioequivalence and Bioavailability Forum • EMA: Veterinary (!) BE

EMA: Veterinary (!) BE [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2012-11-27 00:59 (4167 d 05:21 ago) – Posting: # 9597
Views: 3,034

Hi Querty!

Next time please state already in the first place what you are talking about. In the Vet. BE GL the stupid stuff from the human draft BE GL was copypasted 1:1. Obviously nobody commented on this nonsense (like on the BE draft). Now you have two options:

Switch off your brain, fire up SAS, and report all effects and their CIs as requested.
State already in the protocol that you well aware of the GL, but refer also to the human GL – where this nonsensical requirement was removed. Search the forum for some background discussions in order to get some support in giving a justification (period effect, sequence effect, treatment effect). See also this oldie (slides 40–50).

Up to you.

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

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Complete thread:

EMEA CI on treatment, period & sequence effects qwerty12 2012-11-26 22:11 [Regulatives / Guidelines]
- EMA: no CI on period & sequence effects Helmut 2012-11-26 22:39
  - EMA: no CI on period & sequence effects qwerty12 2012-11-26 23:16
    - EMA: Veterinary (!) BEHelmut 2012-11-26 23:59