Vet BE Guideline [Power / Sample Size]

posted by mittyri – Russia, 2024-02-05 17:49 (19 d 22:26 ago) – Posting: # 23857
Views: 348

Hi Helmut and BEQool!

❝ ❝ France and Ireland - however, it was for veterinary product

❝ This might explain it. The last time I read the vet-GL it was crap (politely speaking).

That's interesting how CHMP EMA Guidelines invade CVMP Guidelines. I am trying to catch the logic:

For substances with highly variable disposition where it is difficult to show bioequivalence due to high intra-individual variability, different alternative designs have been suggested in the literature (e.g. replicate study design). A replicate cross-over study design using 3 periods (partial replication where only the reference product is replicated in all animals) or 4 periods (full replication, where each subject receives the test and reference products twice) can be carried out.
So CVMP people have some concerns about other designs we don't know yet.:-D

Kind regards,

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