Bioequivalence and Bioavailability Forum • Test samples expired for FED study

Test samples expired for FED study [Regulatives / Guidelines]

posted by ElMaestro – Belgium?, 2020-03-05 21:27 (230 d 20:14 ago) – Posting: # 21212
Views: 2,683

Hi,

» How can we conduct fed study. What are the challenges we can face after filing.

Retest, extend the shelf life if within specs, release for CT?

—
I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

Complete thread:

Test samples expired for FED study taiyab.jameel 2020-03-05 10:02 [Regulatives / Guidelines]
- Test samples expired for FED study jag009 2020-03-05 21:57
  - Test samples expired for FED study taiyab.jameel 2020-03-06 04:15
    - Different batches Helmut 2020-03-06 11:21
      - Different batches taiyab.jameel 2020-03-06 12:26
        
        Different batches Marcelo Davanco 2020-03-06 12:37
        
        Different batches wienui 2020-03-07 16:10
        
        The soft-spoken voice of reason Helmut 2020-03-07 22:04
        Different batches Marcelo Davanco 2020-03-08 00:32
        
        Different batches wienui 2020-03-08 10:19
- Test samples expired for FED studyElMaestro 2020-03-05 22:27
  - Test samples expired for FED study Dr_Dan 2020-03-11 11:39