Bioequivalence and Bioavailability Forum • Different batches

Different batches [Regulatives / Guidelines]

posted by wienui – Germany/Oman, 2020-03-08 11:19 (1679 d 23:38 ago) – Posting: # 21225
Views: 4,257

Hi Marcelo,

❝ I agree with you. It was just a suggestion based on our previous experience in Brazil :-| . Sometimes we need to explain the inexplicable to health authority to avoid delays in the dossier review :-D

The use of a different batch in the fed study as asked above from taiyab.jameel could be better as you can prove batches therpeutic equivalence consistency via in vivo studies.

On the contrary, in the case of additional strength biowaiver, it is a must to use the same biobatch for which the therpeutic equivalence was proven before via in vivo BE study.

Best regards,

—
Cheers,
Osama

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 batcheswienui 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