Primidone BE study for USFDA submission [Regulatives / Guidelines]

posted by Ramesh Ramalingam  – India, 2018-04-09 05:54  – Posting: # 18654
Views: 1,645

Dear All,

Till now, USFDA has not issued product specific bioequivalence recommendation to conduct the Primidone BE study. Any one could suggest, what to estimate in the Primidone BE study for USFDA submission, Whether required to estimate parent (Primidone) and metabolite Phenobarbital and phenylethylmalonamide (PEMA) or parent only?


Regards,
Ramesh.R


Edit: Relax; see also this post #9. I deleted your other post which is less than two days old… [Helmut]

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,286 posts in 4,100 threads, 1,317 registered users;
online 12 (1 registered, 11 guests [including 10 identified bots]).

I try not to think with my gut.
If I’m serious about understanding the world,
thinking with anything besides my brain, as tempting as that might be,
is likely to get me into trouble.    Carl Sagan

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5