Retention period and quantity for Malaysian submission [Regulatives / Guidelines]

posted by cakhatri – India, 2020-08-10 08:04 (730 d 09:19 ago) – Posting: # 21848
Views: 1,273

Dear Sriram,

Malaysia has adopted BE guidelines from EMA. Hence you can follow EU guidelines for retention quantity

You can refer section 4.1

The calculation of samples required for retention quantity shall be provided by the sponsor and retained by the site


Complete thread:

UA Flag
 Admin contact
22,292 posts in 4,666 threads, 1,584 registered users;
online 7 (1 registered, 6 guests [including 3 identified bots]).
Forum time: Wednesday 17:23 CEST (Europe/Vienna)

There ain’t no rules around here!
We’re trying to accomplish something!    Thomas Alva Edison

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