Different batches [Regulatives / Guidelines]

posted by wienui  – Germany, Oman, 2020-03-07 16:10 (314 d 09:20 ago) – Posting: # 21222
Views: 2,662

(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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