Bioequivalence and Bioavailability Forum

Hello everyone
During bioanalysis we noticed samples with potential samples switch (two to three samples only), hence we performed reanalysis for this reason, the authority raised concerns about this, we proposed to the authority to use the original concentration as an evidence for Bioequivalence, is this sufficient
Thanks in advance

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Our question is:
Is the use of the original, pre-reanalysis concentration results – supported by available documentation and investigation records – con­sidered sufficient and acceptable evidence for the bioequivalence conclusion, given that the reanalysis was triggered due to suspected sample switch in only a limited number of samples? Furthermore, what additional justification, documentation, or procedural steps would be required to ensure regulatory acceptance in this situation?

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We currently have an ongoing authority audit, and the auditor has raised this question and we proposed this solution. As this point is under active discussion, we kindly request your guidance and a official response.

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Edit: Instead of replying to your own post, please edit it. I deleted your follow-up posts and merged them into this one. [Helmut]