Bioequivalence and Bioavailability Forum

CV%-intra > CV%-inter [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2009-04-11 15:19 (6278 d 10:43 ago) – Posting: # 3511
Views: 37,219

Dear Ravi!

❝ In one of the BE crossover biostudy we performed, it was observed that CV_intra > CV_inter.

Interesting!

❝ […] how does it affects the study analysis. Do we have to use the same apporach 80-125% for establishing BE […]

Yes. But you may obtain a negative variance component in the random term subject(sequence) which calls for treating this effect as fixed. An example is given in the data-set of the Canadian guideline.

❝ […] or we have to modify/change our study design.

How will you modify the design once the study is finished?

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


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Science Quotes

Complete thread:

• Intra subject CV% and Inter subject CV% Ravi 2009-04-11 08:35 
  • CV%-intra > CV%-interHelmut 2009-04-11 13:19
    • CV%-intra > CV%-inter Ravi 2009-04-14 06:01
    • CV%-intra > CV%-inter kvitamin 2009-10-07 11:40
      • Proc MIXED CV%-intra, CV%-inter d_labes 2009-10-07 13:05
        • Proc MIXED CV%-intra, CV%-inter kvitamin 2009-10-07 16:15
          • MIXED up and lost in design d_labes 2009-10-07 16:48
            • MIXED up and lost in design kvitamin 2009-10-08 10:50
              • 2x2, inter, intra, total or what d_labes 2009-10-08 13:41
                • 2x2, inter, intra, total or what kvitamin 2009-10-09 11:05