Bioequivalence and Bioavailability Forum • Different batches

Different batches [Regulatives / Guidelines]

posted by wienui – Germany/Oman, 2020-03-07 17:10 (1509 d 08:45 ago) – Posting: # 21222
Views: 3,635
(edited by wienui on 2020-03-07 17:56)

Hi All,

❝ 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.

Why send a justification which is not needed?

It is nothing against to use a different batch's for different studies for the the same drug.

Best regards,

—
Cheers,
Osama

Complete thread:

Test samples expired for FED study taiyab.jameel 2020-03-05 10:02
- 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 batcheswienui 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