Bioequivalence and Bioavailability Forum

❝ For an example see this presentation (Case 1, slides 4–7). If NCA would have been performed unblinded (i.e., by treatment) the carry-over likely would not have been detected.

Dear Helmut,
Thank you very much!
what does PPT slides 11 means?
– Blinded review of data for irregular profiles?
• EMA
– According the Bioanalytical Method Validation Guideline
measured results are ‘carved from stone’
» Exclusion of data only possible if documented error
» Not even repeated analysis acceptable
• FDA
– Was acceptable until 2022
» Exclusion after repeated analysis possible if defined by SOP
– Currently like EMA

In China, it's common to discuss PK parameters (without treatment assignment, such as pre-dose concentration, abnormal PK concentration profiles, λz estimation, %AUCextrap etc.) to decide analysis set in data review meeting before database lock, is it still compliant with regulatory?

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]