Bioequivalence and Bioavailability Forum

Slowly going OT: BE study simulations [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2016-02-13 16:02 (3777 d 12:07 ago) – Posting: # 15989
Views: 38,717

Dear Ohlbe,

❝ Well, cough... I your example there is not much difference for AUC, agreed. But Cmax ? A difference of 4 points in the point estimate, …

Actually 5.9%!

❝ … closer to 1 with the lousy method, with 90 % CI of 78.6 - 99.8 % with the lousy method against 71.1 - 96.4 % with the good method... In this specific example I would say that yes, it could have mattered, and made a difference between a failing study and a passing study !

Agreed. I guess the difference would have been smaller if we didn’t stop the LC/MS-MS method after 12 subjects (in the good ol’ days of plausibility reviews). The lousy method was validated and all batches passed. Nowadays such a method likely would not survive the ISR.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• Baseline correction vs non-baseline cor­rection jag009 2015-09-15 20:29 
  • Baseline correction vs non-baseline correction Lucas 2015-09-16 14:16
    • Baseline correction vs non-baseline correction Relaxation 2015-09-18 10:25
  • Baseline correction or supra-thera­peu­tic dose Helmut 2015-09-16 15:16
    • Baseline correction or supra-thera­peu­tic dose Ohlbe 2015-09-16 17:55
      • Baseline profile prior to each period? Helmut 2015-09-16 18:15
      • Baseline correction examples Helmut 2015-09-17 15:44
        • Baseline correction examples Lucas 2015-09-18 14:19
          • Baseline correction examples Helmut 2015-09-18 17:28
            • Baseline correction examples Mauricio Sampaio 2016-02-07 03:05
              • Baseline correction examples Lucas 2016-02-10 11:48
                • Postmenopausal women Helmut 2016-02-10 12:26
                • Baseline correction examples Mauricio Sampaio 2016-02-11 01:38
                • Baseline correction examples Dr_Dan 2016-02-11 09:22
                  • Postmenopausal women Mauricio Sampaio 2016-02-12 03:24
                    • Postmenopausal women Dr_Dan 2016-02-15 17:45
            • Baseline correction examples BEQool 2024-11-11 07:34
              • Baseline correction GeoMean and Median mittyri 2024-11-11 11:20
                • Geometric mean? Helmut 2024-11-11 14:53
                  • Geometric mean? BEQool 2024-11-14 08:19
                    • Geometric mean ≈ MLE of median Helmut 2024-11-14 09:54
                      • Geometric mean ≈ MLE of median Mahmoud 2024-11-15 11:26
                        • Bias? Helmut 2024-11-16 08:43
                          • Bias? Mahmoud 2024-11-16 11:12
      • Baseline; another example Helmut 2015-09-18 17:16
        • Baseline; another example nobody 2016-02-12 09:10
          • Baseline; another example Helmut 2016-02-12 13:37
            • Baseline; another example nobody 2016-02-12 14:08
              • Slowly going OT: BE study simulations Helmut 2016-02-12 15:47
                • Slowly going OT: BE study simulations nobody 2016-02-12 16:15
                  • Religious debate Helmut 2016-02-12 17:04
                    • Religious debate nobody 2016-02-12 17:26
                      • Religious debate ElMaestro 2016-02-13 12:53
                        • Religious debate nobody 2016-02-14 15:23
                • Slowly going OT: BE study simulations Ohlbe 2016-02-13 13:10
                  • Slowly going OT: BE study simulationsHelmut 2016-02-13 15:02
                    • Slowly going OT: BE study simulations lizhao 2016-02-25 17:31
                      • Business as usual Helmut 2016-02-25 17:44
                        • Business as usual lizhao 2016-02-25 17:59