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RegisterBiowaiver for Lower Strength [Regulatives / Guidelines]
Dear vandee,
» Can a BE biowaiver for the lower strength be considered if only the lower strength meets this <5% API of tablet core weight requirement? The higher strength has 5.88% of API content per tablet core weight and passed BE.
The 5% criterion applies to both strengths, lower and higher.
» Can a BE biowaiver for the lower strength be considered if only the lower strength meets this <5% API of tablet core weight requirement? The higher strength has 5.88% of API content per tablet core weight and passed BE.
The 5% criterion applies to both strengths, lower and higher.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Biowaiver for Lower Strength vandee 2020-11-23 06:52 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for Lower StrengthOhlbe 2020-11-23 10:41
- Biowaiver for Lower Strength vandee 2020-11-25 06:17
- Biowaiver for Lower Strength wienui 2020-11-24 10:42
- Biowaiver for Lower Strength vandee 2020-11-25 06:21
- Biowaiver for Lower StrengthOhlbe 2020-11-23 10:41
Ing. Helmut Schütz