Bioequivalence and Bioavailability Forum

Baseline correction examples [Regulatives / Guidelines]

posted by Mauricio Sampaio  – Brazil, 2016-02-07 04:05 (2998 d 17:35 ago) – Posting: # 15939
Views: 16,857

Hi Lucas and Helmut

»No method is “perfect”. What about performing such a study in postmenopausal women?❝

Yes! This is my doubt! Why worry with high fluctuations in the endogenous baseline due to cir­ca­dian rhythms to some hormones, as Estradiol, for example, if is possible performing the study with healthy, physiologically or surgically postmenopausal females, single-dose and blood samples colected no more than 96 hours (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM238055)?

The levels should be low and stable, because the circulating estradiol after menopause is approximately 10-20 pg / ml and the greater part of which is derived from peripheral conversion of estrone.

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 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 examplesMauricio 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; 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