Biowaiver for lower strength [Study Per­for­mance]

posted by luvblooms  – India, 2021-08-18 10:34 (162 d 00:39 ago) – Posting: # 22527
Views: 746

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).


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~

Complete thread:

 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 11 (0 registered, 11 guests [including 8 identified bots]).
Forum time: Thursday 10:13 CET (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz