Bioequivalence and Bioavailability Forum

Blinded review of PK data: History… [Study Per­for­mance]

posted by kimhuang – China, 2023-10-16 02:43 (56 d 09:25 ago) – Posting: # 23759
Views: 1,003

Dear Helmut,
Thank you very much for your detailed explanation, these stories are very interesting, gaving me a deeper understanding!

❝ ❝ 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?

❝ Fine, makes sense scientifically. We did that for decades. But regulations ≠ science. At least for the FDA and EMA a blinded review of PK data is no more allowed – except assessing pre-dose concentrations. We are even allowed to re-analyze those. Schizo­phre­nic, IMHO.

Now, how we can to handle λz estimation (eg, R square <0.8) and %AUCextrap etc (<80%)? Nothing to do, just include all subject in primary analysis? And exclude such subject as sensitivity analysis?
Thank you very much!

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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]

Complete thread:

• open-label BE trials maintain blindness kimhuang 2023-10-14 09:19 [Study Per­for­mance] 
  • Blinded NCA Helmut 2023-10-14 10:40
    • Blinded NCA kimhuang 2023-10-14 11:53
      • Blinded review of PK data: History… Helmut 2023-10-15 10:26
        • Blinded review of PK data: History…kimhuang 2023-10-16 00:43
  • open-label BE trials maintain blindness ElMaestro 2023-10-14 17:39
    • open-label BE trials maintain blindness kimhuang 2023-10-15 00:56
      • open-label BE trials maintain blindness dshah 2023-10-17 09:25
        • open-label BE trials maintain blindness kimhuang 2023-10-18 00:50