Different batches [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2020-03-07 17:10 (1068 d 17:57 ago) – Posting: # 21222
Views: 3,255

(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

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