Bioequivalence and Bioavailability Forum

WHO BTIF [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2012-01-13 19:54 (5264 d 10:52 ago) – Posting: # 7939
Views: 6,814

Dear Ohlbe!

❝ ❝ ❝ its possible to compare our study report with reference literature?

❝ ❝ Sure, but of limited value.

❝ On a PK and BE point of view, I would say the global CV has no value at all.

I did not mean a comparison of the CV but of the means. But you are right, Karthik likely meant CVs.

❝ But I've heard some regulators say that they have seen studies with a global CV which was surprisingly low (10 %, for AUC and Cmax). When inspected, the studies turned out to be totally invented, falsified... So on a regulatory point of view, the global CV and its comparison with other trials (including literature data) may provide some other level of information...

Absolutely. A CV_total of 10% is not possible. Maybe for a bunch of monozygotic twins. Even then a very narrow BMI range must be observed. Should ring all alarm bells. BTW, twins (or even better clones) violate the assumption of independence of the statistical model.

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


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Complete thread:

• WHO BTIF K2K 2012-01-12 05:15 [Regulatives / Guidelines] 
  • WHO BTIF Helmut 2012-01-12 13:55
    • WHO BTIF K2K 2012-01-13 05:51
      • WHO BTIF Helmut 2012-01-13 17:05
        • WHO BTIF Ohlbe 2012-01-13 18:41
          • WHO BTIFHelmut 2012-01-13 18:54
            • WHO BTIF K2K 2012-01-16 12:51
              • Inter- or intra-subject CV? Helmut 2012-01-16 13:26
                • intrasubject K2K 2012-01-16 13:35
                  • intrasubject Helmut 2012-01-16 14:50
                    • intrasubject K2K 2012-01-18 09:36