Bioequivalence and Bioavailability Forum

Dear Ohlbe,

❝ ❝ The % recovery across all concentration levels (i.e LOW ,MED add High) should be consistent that means %CV should be within 20% across all levels

%CV for % recoveries across Low, med and high level shall be within 20 %.

❝ Why 30% to 120% ? Where do these values come from ?

This is just example. You can keep accepted % recovery as 25 % to 125 % etc. in you SOP,but in guideline % recovery criteria no where mentioned but many industries had included acceptance criteria of % recovery in their SOP.

Thanks ,
Kintan Patel

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]