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 22:27 – Posting: # 21212
Views: 1,951

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

"Pass or fail" (D. Potvin et al., 2008)

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