Biowaiver for lower strength [Study Performance]
❝ 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).
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~