Remaining RLDs from pilot study [Regulatives / Guidelines]

posted by qualityassurance – 2023-09-28 14:29 (267 d 04:19 ago) – Posting: # 23726
Views: 1,393

Dear Mr. Osama,

❝ No, You can't use the rest of the reference drug for conducting a BE Study with a new ordered reference drug batch, as they are two different Batches (Biobatches).


What if sponsor sent 1 bottle containing 56 tabs. of RLD to CRO for pilot study from which only 12 tabs. were utilized. Can rest of the tablets be used for pivotal study from the same opened bottle of RLD? Of course storage conditions were maintained in pharmacy of CRO.


Regards,
QA

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