Bioequivalence and Bioavailability Forum

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

posted by Relaxation  – Germany, 2015-09-18 12:25 (3136 d 22:25 ago) – Posting: # 15428
Views: 18,865

Hi to everybody.

❝ 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 think a possible explanation for requiring both data sets (presented) may also be that there seems to be a lot of "errors" during evaluations.
I haven't searched for that, but thinking about the maybe last four publications/reports I saw dealing with a baseline and BE: all of them naturally claimed the use of baseline corrected data.
But in reality none of them did.

Some of them clearly stated the erronous way of calculation and presented data for corrected and uncorrected concentrations, that were not plausible, if you knew where to look at (meaning: if the quotient of means (arithmetic, because who would present geometric ones for a PK parameter ) is 0.6, but the point estimate is a 0.9, well...
So there might be just some misunderstandings.

Some of them "forgot" to present all data (even down to give the point estimates/CI and some nice graphs on the maximum time scale only) and described the evaluation in a lot of words with little content.

No way to separate misconduct from unintentional failure here, but the best way to check that is by having both data sets available, so that may be a reason to ask for presentation of both?

Best regards,

Steven.

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 correctionRelaxation 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; 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