Nitrofurantoin BE study [Regulatives / Guidelines]

posted by Relaxation  – Germany, 2021-06-15 14:10 (1477 d 07:14 ago) – Posting: # 22413
Views: 5,198

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:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,679 registered users;
43 visitors (0 registered, 43 guests [including 8 identified bots]).
Forum time: 21:25 CEST (Europe/Vienna)

Fools with Tools Are Still Fools!    Anonymous

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