Bioequivalence and Bioavailability Forum • please explain your opinion regarding ICH E9

please explain your opinion regarding ICH E9 [Regulatives / Guidelines]

posted by mittyri – Russia, 2016-08-29 17:12 (3588 d 08:05 ago) – Posting: # 16609
Views: 6,969

Hi David,

could you please explain this:

❝ According to ICH E9:

❝ "The main treatment effect may be investigated first using a model which allows for centre differences, but does not include a term for treatment-by-centre interaction. <...>"

❝ The model would include centre, centre*form and subject(sequence*centre).

centre*form - does that mean Centre*Formulation? If yes, doesn't it contradict the cite above?

ElMaestro suggested just to add the group effect

—
Kind regards,
Mittyri

Complete thread:

multicenter crossover bioequivalent study Yura 2016-08-29 08:10
- ICH E9 has the answer DavidManteigas 2016-08-29 13:55
  - please explain your opinion regarding ICH E9mittyri 2016-08-29 15:12
    - please explain your opinion regarding ICH E9 DavidManteigas 2016-09-01 13:47
  - ICH E9 has the answer Yura 2016-08-29 15:16
  - ICH E9 has the answer BE-proff 2016-08-30 08:31
- Winter is coming to EEU mittyri 2016-08-29 15:03