Bioequivalence and Bioavailability Forum • Baseline correction examples

Baseline correction examples [Regulatives / Guidelines]

posted by Lucas – Brazil, 2016-02-10 12:48 (3390 d 11:55 ago) – Posting: # 15969
Views: 23,470

Hi Mauricio!

The issue with that, at least here in Brazil, is recruiting post-menopause healthy subjects. We see a lot of failed pre study exams results like cholesterol, BMI out of range, etc. So it is not that easy to recruit these women, usually taking a lot of extra time in recruitment and screening. But it would be far more easy to conduct BE studies of female hormones with them, and at least ANVISA accepts it so far. I wouldn't know about FDA and EMA, but I think that they'd accept as well. Baseline levels of estradiol are a nightmare in healthy fertile women...

Regards

Lucas

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 examplesLucas 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