Bioequivalence and Bioavailability Forum

Baseline correction vs non-baseline correction [Regulatives / Guidelines]

posted by Lucas – Brazil, 2015-09-16 16:16 (3927 d 01:26 ago) – Posting: # 15405
Views: 42,023

Hello John!

I don't think that this is a stupid question at all. I've always wondered that. When you ask for both results but says that only the corrected should be considered in BE determination, then why present both??

I'm not sure if in the US both are mandatory, but here only corrected data determine BE, and uncorrected should be presented. That's maybe only to confuse, because I've seen different conclusions for corrected and uncorrected data...

I'm also not sure about the correction based on three basal sampling points, taken very close to the drug administration. We've conducted a estradiol study recently and the basal levels for it were a nightmare, really really bizarre. We observed curves that were almost completely below the basal level, implying that the basal level is not even near constant through the Pk sampling schedule.

So if anyone can shed a light on that, I would also be pleased.


thx

Lucas

Complete thread:

• Baseline correction vs non-baseline cor­rection jag009 2015-09-15 20:29 
  • Baseline correction vs non-baseline correctionLucas 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 simulations Helmut 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