Biowaiver for lower strength [Study Per­for­mance]

posted by luvblooms  – India, 2021-08-18 12:34 (1038 d 07:45 ago) – Posting: # 22527
Views: 2,141

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~

Complete thread:

UA Flag
Activity
 Admin contact
23,059 posts in 4,841 threads, 1,664 registered users;
45 visitors (0 registered, 45 guests [including 4 identified bots]).
Forum time: 20:20 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5