Bioequivalence and Bioavailability Forum • Retention period and quantity for Malaysian submission

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

posted by cakhatri – India, 2020-08-10 10:04 (1354 d 05:21 ago) – Posting: # 21848
Views: 1,575

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:

Retention period and quantity for Malaysian submission Sriramprasad 2020-07-18 09:06
- Retention period and quantity for Malaysian submissioncakhatri 2020-08-10 08:04
  - Retention period and quantity for Malaysian submission Sriramprasad 2020-10-17 13:54

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