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

posted by nlpati – India, 2022-02-01 06:44 (302 d 02:33 ago) – Posting: # 22767
Views: 10,415

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
22,418 posts in 4,693 threads, 1,598 registered users;
10 visitors (0 registered, 10 guests [including 3 identified bots]).
Forum time: 09:17 CET (Europe/Vienna)

Intellect distinguishes between the possible and the impossible;
reason distinguishes between the sensible and the senseless.
Even the possible can be senseless.    Max Born

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