IMP Retention samples for Brazil BA BE studies [Regulatives / Guidelines]

posted by nlpati – India, 2022-02-01 06:44 (1195 d 02:57 ago) – Posting: # 22767
Views: 11,727

Dear Sir / Madam,

Please can you confirm the quantity of reserve samples or retention samples of IMPs required for Brazil submission (BA-BE studies) and also please quote the document which can be referred (if available).

with thanks and regards,
Lpati

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,668 registered users;
119 visitors (0 registered, 119 guests [including 9 identified bots]).
Forum time: 10:42 CEST (Europe/Vienna)

Lack of clarity is always a sign of dishonesty.    Celia Green

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