Different batches [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2020-03-08 11:19 (1451 d 03:26 ago) – Posting: # 21225
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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

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