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RegisterBiowaiver for lower strength [Study Performance]
Hi Vishal
A common problem with drugs that have dose-dependent solubility.
The best way to handle this scenario is to go with does equivalent dissolution approach (assuming your formulation is dose-proportional).
Example:
2.5 mg *8 vs 20 mg
5 mg*4 vs 20
10mg *2 vs 20
There are few SBoA's available where FDA has recommended this approach.
I am trying to find those and will update the post if I am able to get those.
❝ clarification-after in vitro testing, the 2.5mg strength does not show proportional similarity and acceptable in vitro dissolution testing.
A common problem with drugs that have dose-dependent solubility.
The best way to handle this scenario is to go with does equivalent dissolution approach (assuming your formulation is dose-proportional).
Example:
2.5 mg *8 vs 20 mg
5 mg*4 vs 20
10mg *2 vs 20
There are few SBoA's available where FDA has recommended this approach.
I am trying to find those and will update the post if I am able to get those.
—
~A happy Soul~
~A happy Soul~
Complete thread:
- Biowaiver for lower strength Vishal S 2021-08-06 11:12 [Study Performance]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for lower strength drgunasakaran1 2021-08-06 14:47
- Biowaiver for lower strength Vishal S 2021-08-09 08:55
- Biowaiver for lower strengthluvblooms 2021-08-18 10:34
- Biowaiver for lower strength Vishal S 2021-08-09 08:55
- Biowaiver for lower strength drgunasakaran1 2021-08-06 14:47
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