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RegisterBiowaiver criterion <5% (not ≤5%) [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2022-08-12 14:17 (1008 d 20:56 ago) – Posting: # 23219
Views: 3,410
Hi Laura,
Do you have rounding here, say, 5.0049% → 5.00%?
Even if not, ‘less than’ ≠ ‘less or equal than’…
❝ ![[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?
Do you have rounding here, say, 5.0049% → 5.00%?
Even if not, ‘less than’ ≠ ‘less or equal than’…
—
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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