Baseline correction or supra-therapeutic dose [Regulatives / Guidelines]
Dear Helmut,
I can see one theoretical situation which could be tricky. I don't know whether you have come across anything like this.
Many endogeneous compounds follow a circadian rythm. What if the concentrations at 8 AM are higher than in the evening ? Negative concentrations after baseline correction will be replaced with 0. Couldn't this artificially decrease the difference between formulations, compared with a non-baseline-corrected analysis ? I mean, if formulation A gives concentrations 50 % lower than formulation B, both negative after baseline correction and reset to 0...
❝ first of all I agree with Lucas. I don’t get the idea of basing BE on uncorrected data.
I can see one theoretical situation which could be tricky. I don't know whether you have come across anything like this.
Many endogeneous compounds follow a circadian rythm. What if the concentrations at 8 AM are higher than in the evening ? Negative concentrations after baseline correction will be replaced with 0. Couldn't this artificially decrease the difference between formulations, compared with a non-baseline-corrected analysis ? I mean, if formulation A gives concentrations 50 % lower than formulation B, both negative after baseline correction and reset to 0...
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Baseline correction vs non-baseline correction jag009 2015-09-15 20:29 [Regulatives / Guidelines]
- 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 doseOhlbe 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
- Postmenopausal women Mauricio Sampaio 2016-02-12 03:24
- Baseline correction examples Lucas 2016-02-10 11:48
- 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
- Geometric mean ≈ MLE of median Helmut 2024-11-14 09:54
- Geometric mean? BEQool 2024-11-14 08:19
- Geometric mean? Helmut 2024-11-11 14:53
- Baseline correction GeoMean and Median mittyri 2024-11-11 11:20
- Baseline correction examples Mauricio Sampaio 2016-02-07 03:05
- Baseline correction examples Helmut 2015-09-18 17:28
- Baseline correction examples Lucas 2015-09-18 14:19
- 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
- Religious debate ElMaestro 2016-02-13 12:53
- Religious debate nobody 2016-02-12 17:26
- Religious debate Helmut 2016-02-12 17:04
- 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
- Business as usual Helmut 2016-02-25 17:44
- Slowly going OT: BE study simulations lizhao 2016-02-25 17:31
- Slowly going OT: BE study simulations Helmut 2016-02-13 15:02
- Slowly going OT: BE study simulations nobody 2016-02-12 16:15
- Slowly going OT: BE study simulations Helmut 2016-02-12 15:47
- Baseline; another example nobody 2016-02-12 14:08
- Baseline; another example Helmut 2016-02-12 13:37
- Baseline; another example nobody 2016-02-12 09:10
- Baseline correction or supra-therapeutic doseOhlbe 2015-09-16 17:55
- Baseline correction vs non-baseline correction Lucas 2015-09-16 14:16