Bioequivalence and Bioavailability Forum • Expiry date on medicines

Expiry date on medicines [GxP / QC / QA]

posted by drmuneesh – 2009-08-11 09:30 (6166 d 04:36 ago) – Posting: # 4034
Views: 10,772

Dear Helmut
Hi

Thank you very much for the response.

We are planning a 4-period replicate study for a highly variable drug with a long washout of 30 days. But the reference product is getting expired in the month of the last dosing day. Can we go ahead with the study?

And are there any guidelines/document stating that expiry date should be considered as the last day of the month written on the IP to avoid any regulatory queries in future?

Best Regards
Dr Muneesh Garg

Complete thread:

Expiry date on medicines drmuneesh 2009-08-10 16:43
- Expiry date on medicines Helmut 2009-08-10 16:52
  - Expiry date on medicinesdrmuneesh 2009-08-11 07:30
    - 3-way replicate vs. 4-way Helmut 2009-08-11 14:22
      - 3-way replicate vs. 4-way drmuneesh 2009-08-17 05:46
        
        3-way replicate vs. 4-way Helmut 2009-08-20 02:14
        
        3-way replicate vs. 4-way drmuneesh 2009-08-20 09:28
        
        Ethics: no. of administrations Helmut 2009-08-20 14:05
        
        Ethics: no. of administrations drmuneesh 2009-08-21 10:43