Bioequivalence and Bioavailability Forum

Farside CV relabelling [RSABE / ABEL]

posted by Helmut  – Vienna, Austria, 2010-11-09 16:10 (5344 d 22:18 ago) – Posting: # 6121
Views: 14,159

Dear D. Labes!

❝ ❝ Well, I have no idea what Pharsight calculated here …

❝

❝ Me too. Their formula given on the slide

❝   +1.25(sigmaRef/0.25)

❝ is clearly nonsense. It would give negative lower bounds!

Sure. But note that the upper bound is OK, maybe the have calculated L=1/U?

❝ The correct one is

❝   exp(+log(1.25)*sigmaRef/0.25)

❝ I think.

Right – as always.

❝ Taking the numbers for the widened acceptance ranges given, they seems to have a label problem.

Oh no!

❝ Eventually one should remind the author of the slides that labelling falls under the policy of GMP .

I have linked this thread to Pharsight’s Extranet ten hours ago…

❝ BTW:

❝ <nitpicking> ------------------

❝ I get for the FDA's widened limits: [...]

❝ </nitpicking> ------------------

Me too – even with bloody M$-Excel (excuse me, Martin). Don’t know what László has done here. Was too late to produce a nice looking plot in R…

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


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Science Quotes

Complete thread:

• reference scaled bioequivalence AngusMcLean 2010-11-07 14:55 [RSABE / ABEL] 
  • reference scaled bioequivalence Helmut 2010-11-07 16:08
    • reference scaled bioequivalence AngusMcLean 2010-11-08 22:22
      • RSABE: FDA vs. EMA Helmut 2010-11-09 02:13
        • Farside CV relabelling d_labes 2010-11-09 10:42
          • Farside CV relabellingHelmut 2010-11-09 15:10
            • Laszlo's constant d_labes 2010-11-09 16:46
          • Farside CV relabelling AngusMcLean 2010-11-09 17:12
            • Widened calculations step by step d_labes 2010-11-09 19:48
              • Widened calculations step by step AngusMcLean 2010-11-09 20:46
                • ln vs. log Helmut 2010-11-09 22:07
                • ln on US calculators! d_labes 2010-11-10 08:31
                  • Spreadsheet addiction Helmut 2010-11-10 13:42
            • CV vs. sigma Helmut 2010-11-09 20:11
              • CV vs. sigma AngusMcLean 2010-11-09 20:57
                • log(e) vs. log(10) Helmut 2010-11-09 21:31
              • slide 15 of the Pharsight presentation SDavis 2010-11-19 18:02
        • one more ref. for the ref. list of RSABE yjlee168 2010-11-30 07:16
          • Great! Helmut 2010-11-30 15:44