Bioequivalence and Bioavailability Forum

Missing values [Study Per­for­mance]

posted by Helmut  – Vienna, Austria, 2008-07-30 19:14 (6542 d 00:13 ago) – Posting: # 2109
Views: 20,862

Dear Martin,

I’m with you in the definition of data sets (especially PKAS(b) etc. etc.)…
The important point is an a-priori strategy, which has to be adapted according to the PK characteristics of the drug, etc.

❝ regarding the importance of FADS and PADS: the FADS should reflect the clinical situation in practice better than the rather artificial PADS and is according to my point of view more important.

Yes, but phase I trials never reflect the clinical situation.
IMPs in a BE study are not labeled for sole use in healthy male Caucasian^* subjects, preferably non-smokers of a BMI [19-27] fasting four hours after administration together with 150 mL non-carbonated water of ambient temperature avoiding methyl-xanthine containing food and beverages as well as grapefruit juice, charcoal broiled meat and broccoli during the study (did I forget something?).
A properly designed BE study should be powered to be able to detect differences between formulations in the smallest possible number of subjects – which we hope to attain by a high degree of standardization. This has nothing in common with the clinical situation.

❝ […] thanks for the very interesting discussion

Same to you!

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• ‘Caucasian’ is an outdated racist concept and has nothing to do with (pharmaco)genetics…

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Science Quotes

Complete thread:

• Missing values ratnakar1811 2008-04-02 14:07 [Study Per­for­mance] 
  • Missing values Helmut 2008-04-02 14:54
    • Missing values atish_azad 2008-07-29 11:03
      • Missing values ElMaestro 2008-07-29 11:21
        • Missing values Helmut 2008-07-29 21:40
          • Missing values ElMaestro 2008-07-31 10:38
            • Missing values Helmut 2008-07-31 14:36
      • Missing values Helmut 2008-07-29 21:18
  • Missing values martin 2008-07-29 13:56
    • Missing values Helmut 2008-07-29 22:18
      • Missing values martin 2008-07-30 10:28
        • ITT vs. PP data sets Helmut 2008-07-30 13:30
        • Missing values d_labes 2008-07-30 13:39
          • Missing values Helmut 2008-07-30 14:34
          • Missing values martin 2008-07-30 14:50
            • Missing valuesHelmut 2008-07-30 17:14
              • Missing values d_labes 2008-07-31 09:18