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

posted by nlpati – India, 2022-02-01 06:44 (1195 d 19:32 ago) – Posting: # 22767
Views: 11,729

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, 1,672 registered users;
127 visitors (0 registered, 127 guests [including 7 identified bots]).
Forum time: 03:16 CEST (Europe/Vienna)

If you shut your door to all errors
truth will be shut out.    Rabindranath Tagore

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