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

posted by cakhatri – India, 2020-08-10 08:04 (45 d 15:19 ago) – Posting: # 21848
Views: 658

Dear Sriram,

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

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/2005_12_14_annex19_en.pdf

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

Regards
Chirag

Complete thread:

Activity
 Admin contact
21,074 posts in 4,394 threads, 1,468 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Thursday 23:24 CEST (Europe/Vienna)

Enlightenment is man’s emergence from his self-imposed nonage
for which he himself was responsible.
Nonage is the inability to use one’s own intellect
without the direction of another.    Immanuel Kant

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