Primidone BE study for USFDA submission [Regulatives / Guidelines]

posted by Ramesh Ramalingam  – India, 2018-04-09 07:54 (2497 d 23:49 ago) – Posting: # 18654
Views: 5,239

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:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,665 registered users;
163 visitors (0 registered, 163 guests [including 5 identified bots]).
Forum time: 06:43 CET (Europe/Vienna)

There are sadistic scientists who hurry to hunt down errors
instead of establishing the truth.    Marie Curie

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