Bioequivalence and Bioavailability Forum

Outlier in fully replicate BE study [Outliers]

posted by Loky do – Egypt, 2021-06-16 02:49 (1044 d 03:18 ago) – Posting: # 22414
Views: 4,521

Dear colleagues,

During bioanalysis of a fully replicate BE study for drug known to has a potential for back conversion (clopidogrel), one volunteer shows drug concentrations below LLOQ in 3 phases and only one phase (Reference product) shows very low drug concentration, no probability of not swallowing the tablets (mouth check was assured) what could be the reason of this results ? Knowing that the ISR results for the study is accepted?
Thanks in advance

Complete thread:

• Outlier in fully replicate BE studyLoky do 2021-06-16 00:49 [Outliers] 
  • Outlier in fully replicate BE study drgunasakaran1 2021-06-16 08:59
    • Widening for clopidogrel BE study Loky do 2021-06-16 15:38
      • Widening for clopidogrel BE study mittyri 2021-06-16 16:04
        • Widening for clopidogrel BE study Loky do 2021-06-16 17:08
          • Widening for clopidogrel BE study - cherry-picking? mittyri 2021-06-16 17:27
          • Widening for clopidogrel BE study drgunasakaran1 2021-06-17 12:01
          • Hypotheses Helmut 2021-06-19 12:32
            • Hypotheses Loky do 2021-07-06 11:51
              • ABEL ≠ RSABE Helmut 2021-07-06 16:17
                • ABEL ≠ RSABE BEQool 2023-10-09 14:47
                  • power.TOST.sim and uncertainty mittyri 2023-10-11 12:42
                    • power.TOST.sim and uncertainty BEQool 2023-10-15 11:29
                      • power.TOST.sim and uncertainty mittyri 2023-10-20 21:47
                        • Distribution of PEs Helmut 2023-10-23 10:48
                          • Distribution of PEs BEQool 2023-10-23 19:55
                            • power.TOST.sim code mittyri 2023-10-31 15:40
                              • power.TOST.sim code BEQool 2023-11-02 11:22