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RegisterBiowaiver criteria - 5% [Regulatives / Guidelines]
Hello everyone!
As described in the bioequivalence guideline:
![[image]](img/uploaded/image837.png)
I would like to know if anyone has experience with a similar situation. If the active substance is equal to 5.00% of the tablet core weight, can it be considered proportional?
Thank you in advance for the help.
As described in the bioequivalence guideline:
I would like to know if anyone has experience with a similar situation. If the active substance is equal to 5.00% of the tablet core weight, can it be considered proportional?
Thank you in advance for the help.
Complete thread:
- Biowaiver criteria - 5%Laura Carreiras 2022-08-12 12:03 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver criterion <5% (not ≤5%) Helmut 2022-08-12 12:17
- Biowaiver criterion <5% (not ≤5%) Laura Carreiras 2022-08-12 12:37
- Biowaiver criterion <5% (not ≤5%) wienui 2022-08-16 18:22
- Biowaiver criterion <5% (not ≤5%) Laura Carreiras 2022-08-12 12:37
- Biowaiver criterion <5% (not ≤5%) Helmut 2022-08-12 12:17
Ing. Helmut Schütz