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

posted by cakhatri – India, 2020-08-10 06:04 (272 d 01:58 ago) – Posting: # 21848
Views: 1,022

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
21,445 posts in 4,482 threads, 1,510 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time: Sunday 08:03 UTC (Europe/Vienna)

It is better to know some of the questions
than all of the answers.    James Thurber

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