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RegisterBiowaiver for Lower Strength [Regulatives / Guidelines]
Dear All,
I'd like to seek some advice regarding a specific requirement in the EMA BE guidelines biowaiver:
the amount of the active substance(s) is less than 5 % of the tablet core weight, the weight of the capsule content
Is this criteria applicable for both the BE strength and the lower strength aimed for biowaiver? 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. All other biowaiver requirements have been met.
Appreciate any advise i can get on this matter. Thank you very much
I'd like to seek some advice regarding a specific requirement in the EMA BE guidelines biowaiver:
the amount of the active substance(s) is less than 5 % of the tablet core weight, the weight of the capsule content
Is this criteria applicable for both the BE strength and the lower strength aimed for biowaiver? 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. All other biowaiver requirements have been met.
Appreciate any advise i can get on this matter. Thank you very much
Complete thread:
- Biowaiver for Lower Strengthvandee 2020-11-23 06:52 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for Lower Strength Ohlbe 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 Strength Ohlbe 2020-11-23 10:41
Ing. Helmut Schütz