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