Bioequivalence and Bioavailability Forum • Different batches

Different batches [Regulatives / Guidelines]

posted by Marcelo Davanco – Campinas, SP, Brazil, 2020-03-06 12:37 – Posting: # 21220
Views: 1,919

» Can we expect any query on authority or specific requirement, we need to met before study initiation.

In my opinion, it's important only to send a justification letter (considering expiry date of the Fasting condition batches) following the Fed condition BE reports in order to avoid further authority concerns.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

—
Marcelo Davanço

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 batchesMarcelo 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 study ElMaestro 2020-03-05 22:27
  - Test samples expired for FED study Dr_Dan 2020-03-11 11:39