Blinded NCA [Study Performance]
❝ 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.
Thank you very much!
what does PPT slides 11 means?
– Blinded review of data for irregular profiles?
– 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
– 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?
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]
- open-label BE trials maintain blindness kimhuang 2023-10-14 09:19 [Study Performance]
- Blinded NCA Helmut 2023-10-14 10:40
- open-label BE trials maintain blindness ElMaestro 2023-10-14 17:39