Primidone BE study for USFDA submission [Regulatives / Guidelines]

posted by Ramesh Ramalingam  – India, 2018-04-09 05:54 (1293 d 23:59 ago) – Posting: # 18654
Views: 3,796

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?


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

Complete thread:

 Admin contact
21,753 posts in 4,548 threads, 1,544 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Sunday 05:54 CEST (Europe/Vienna)

They were “so intent of making everything numerical”
that they frequently missed seeing
what was there to be seen.    Barbara McClintock

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