Nitrofurantoin BE study [Regulatives / Guidelines]

posted by Relaxation  – Germany, 2021-06-15 12:10 (41 d 13:17 ago) – Posting: # 22413
Views: 468

Hi.

For the interested, the current (draft:-)) version of PSG_009175 is dated May 2021.

»Whether BE Study to be performed with 25 mg ( 5mL) or 100 mg ( 20 mL ) ?

For both, fasted and fed trial given in the product-specific BE guidance:
Strength: 25 mg; 5 mL

Best regards.

Complete thread:

Activity
 Admin contact
21,589 posts in 4,512 threads, 1,530 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Tuesday 01:28 CEST (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

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