Different batches [Regulatives / Guidelines]

posted by Marcelo Davanco Homepage – Campinas, SP, Brazil, 2020-03-08 00:32 (228 d 17:40 ago) – Posting: # 21224
Views: 2,515

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 :-D


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