Solubility based Biowaiver [Dissolution / BCS / IVIVC]

posted by wienui  – Germany, Oman, 2018-10-02 04:52 (1203 d 02:05 ago) – Posting: # 19358
Views: 5,108

(edited by wienui on 2018-10-02 05:14)

Dear Amalia & Scopy,

I agree with Scopy only an important point to mention that the dissolution tests of the lower strength must be conducted against the same Biobatch (the batch which approved via BE study) of the higher strength, otherwise it will not be accepted from the regulatory.

Best regards,

Osama

Cheers,
Osama

Complete thread:

Activity
 Admin contact
21,829 posts in 4,566 threads, 1,554 registered users;
online 7 (0 registered, 7 guests [including 3 identified bots]).
Forum time: Monday 05:57 CET (Europe/Vienna)

Discovery consists of seeing what everybody has seen
and thinking what nobody has thought.    Albert Szent-Györgyi

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