Bioequivalence and Bioavailability Forum • Farside CV relabelling

Farside CV relabelling [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2010-11-09 11:42 (5711 d 19:57 ago) – Posting: # 6118
Views: 17,425

Dear Helmut,

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

Me too. Their formula given on the slide
+1.25^{(sigma_Ref/0.25)}
is clearly nonsense. It would give negative lower bounds!
The correct one is
exp(+log(1.25)*sigma_Ref/0.25)
I think.

Taking the numbers for the widened acceptance ranges given, they seems to have a label problem.
(In German: Wo 35% draufsteht sollte auch 35% drin sein!)
Label their CV=35% with 30%, their CV=40% with 35% and so on and you have perfect coincidence with your values within rounding error :cool:

.
Eventually one should remind the author of the slides that labelling falls under the policy of GMP :-D

.

Full ACK to all other of your points.

BTW:
<nitpicking> ------------------
I get for the FDA's widened limits:

CV 30% 76.95 - 129.96 35% 73.83 - 135.45 40% 70.90 - 141.04 45% 68.16 - 146.71 50% 65.60 - 152.45 55% 63.20 - 158.23 60% 60.96 - 164.04

using R-2.12.0 64bit on my new Intel Core i3 machine with Windows 7 Prof.
</nitpicking> ------------------ :wink:

—
Regards,

Detlew

Complete thread:

reference scaled bioequivalence AngusMcLean 2010-11-07 14:55
- 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 relabellingd_labes 2010-11-09 10:42
        
        Farside CV relabelling Helmut 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