Design [Regulatives / Guidelines]

posted by Pharma_88 – India, 2020-08-27 16:07 (337 d 11:23 ago) – Posting: # 21893
Views: 2,638

Dear All,

We are thinking to perform steady state BE study for XXX submission where Test product is ER formulation and Reference product is IR formulation. Further, Its HVD product. So, question is whether is this feasible to conduct replicate BE IR vs ER and if yes then what are the parameters for conclusion?

Thanks.

Complete thread:

Activity
 Admin contact
21,594 posts in 4,515 threads, 1,532 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Saturday 03:30 CEST (Europe/Vienna)

Restlessness is discontent –
and discontent is the first necessity of progress.
Show me a thoroughly satisfied man 
and I will show you a failure.    Thomas Alva Edison

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