Reference-scaled Bioequivalence [RSABE / ABEL]

posted by AngusMcLean – USA, 2014-03-28 18:48 (4064 d 18:21 ago) – Posting: # 12735
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http://screencast.com/t/dAkRl2NyPwe

I am reading the review paper of Barbara Davit published in Pharm. Research 2013. I have a comprehension problem

See link ABOVE to view the equation towards the top of the page.
It is evident that when σWR=σ W0 then the BE limits are the usual ±Ln 1.25 ie. (1.25, 0.8)
I want to use the equation to evaluate an example of the implied limits when σWR>σ W0 and I selected an example from the paper of σWR =0.7565. σ W0 is set at 0.25 by the Agency.
I am having difficulty following this equation and implementing it. I try and evaluate the right hand side of the equation towards the top of the page in the link attached
Ln (1.25) σWR/σ W0
As I read this equation I am thinking it is Ln(1.25)0.7565/0.25 =0.223*0.7565/0.25 = 0.6747
Or is it in the LN scale
Ln[(1.25) σWR/σ W0]= Ln 3.7825
Please can I be advised as to the evaluation of the right hand side of the equation; also I am interested how one arrives at the evaluation of the left hand side of the equation with the σWR and σ W0 is give.

Angus

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