Biowaiver for lower strength [Study Per­for­mance]

posted by luvblooms  – India, 2021-08-18 12:34 (471 d 13:16 ago) – Posting: # 22527
Views: 1,182

Hi Vishal

❝ 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~

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