Bioequivalence and Bioavailability Forum • Remaining RLDs from pilot study- retention sample?

Remaining RLDs from pilot study- retention sample? [Regulatives / Guidelines]

posted by dshah – India, 2023-10-03 19:27 (594 d 03:56 ago) – Posting: # 23735
Views: 3,206

Dear QA and RK!

❝

❝ 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.

❝

Mostly you would not be able to use for below reasons.
- Does the remaining quantity is sufficient for testing or will you have sufficient retention samples? Generally the RLD samples are directly shipped to CRO and thus sponsor's may not have sufficient quantity of retention samples.

Regards,
Divyen Shah

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    - Remaining RLDs from pilot study- retention sample?dshah 2023-10-03 17:27