Bioequivalence and Bioavailability Forum

Different batches [Regulatives / Guidelines]

posted by Marcelo Davanco  – Campinas, SP, Brazil, 2020-03-08 00:32 (932 d 23:36 ago) – Posting: # 21224
Views: 3,161

Hi Osama,

» 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.

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

BR,
Marcelo

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 batchesMarcelo 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