Bioequivalence and Bioavailability Forum • Remaining RLDs from pilot study

Remaining RLDs from pilot study [Regulatives / Guidelines]

posted by wienui – Germany/Oman, 2023-09-28 20:12 (645 d 11:03 ago) – Posting: # 23727
Views: 3,584

❝ 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.

Dear QA,

Sure in this case you can use the rest of the tablets (same batch Nr.) as long as the expiration date is still valid.

—
Cheers,
Osama

Complete thread:

Test License rajasekharkakarla 2018-10-06 08:05 [Regulatives / Guidelines]
- Test License Obinoscopy 2018-10-06 12:58
- Test License wienui 2018-10-07 21:04
  - Remaining RLDs from pilot study qualityassurance 2023-09-28 12:29
    - Remaining RLDs from pilot studywienui 2023-09-28 18:12
    - Remaining RLDs from pilot study- retention sample? dshah 2023-10-03 17:27