Nitrofurantoin BE study [Regulatives / Guidelines]

posted by AB661 – India, 2021-06-15 09:38 (101 d 01:19 ago) – Posting: # 22412
Views: 879

Dear All,

OGD BE recommendation recently updated. As per New guidance there are two studies ( fasting & Fed) need to be performed. Earlier only fasting study recommended. In current guidance for Dose of Suspension for BE study not mentioned. Whether BE Study to be performed with 25 mg ( 5mL) or 100 mg ( 20 mL ) ?

With regards

Complete thread:

 Admin contact
21,693 posts in 4,535 threads, 1,541 registered users;
online 9 (1 registered, 8 guests [including 3 identified bots]).
Forum time: Friday 10:58 CEST (Europe/Vienna)

Tortured data will confess to anything.    Fredric Menger

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