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RegisterVet BE Guideline [Power / Sample Size]
Hi Helmut and BEQool!
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.
❝ ❝ 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.
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- sampleN.TOST vs. sampleN.scABEL BEQool 2024-01-29 11:53 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ABEL is a framework (decision scheme) Helmut 2024-01-29 13:52
- ABEL is a framework (decision scheme) BEQool 2024-01-30 10:52
- ABEL vs. ABE Helmut 2024-01-30 13:08
- ABEL vs. ABE BEQool 2024-02-04 19:24
- Being able to read does not hurt… Helmut 2024-02-04 21:12
- Being able to read does not hurt… BEQool 2024-02-05 13:20
- Being able to read does not hurt… Helmut 2024-02-05 16:01
- Vet BE Guidelinemittyri 2024-02-05 16:49
- Being able to read does not hurt… Helmut 2024-02-05 16:01
- Being able to read does not hurt… BEQool 2024-02-05 13:20
- Being able to read does not hurt… Helmut 2024-02-04 21:12
- ABEL vs. ABE BEQool 2024-02-04 19:24
- ABEL vs. ABE Helmut 2024-01-30 13:08
- ABEL is a framework (decision scheme) BEQool 2024-01-30 10:52
- ABEL is a framework (decision scheme) Helmut 2024-01-29 13:52
Ing. Helmut Schütz