Bioequivalence and Bioavailability Forum

Ken: you have got a lot of excellent material here. I think you need an SOP, which defines your lab policy. I think you can write one now from your experience and the material given in this forum. In the US the correlation coefficient is not really relevant to the analytical criteria. The SOP I used to use allowed the analyst to drop one aberrant back calculated standard, but criteria were stipulated for that event. The policy with weighted regression was to evaluate the options and if 1/x and 1/x squared are evaluated and give a similar result go with the1/x weighting. Of course if a quadratic option is available then it could be evaluated and preferred.

FDA like to see one general policy in place not one made up on a day to day basis,

Hope this helps,

Angus