Bioequivalence and Bioavailability Forum

dear ohlbe....

refering to your answer by the "crystal city III". I read the paper previously and just revised it, I have some points that I like to discuss.

1- Page E33 CALIBRATION CURVE AND QC RANGES

" it is not necessary to reanalyze samples analyzed before optimizing the standard curve or QC concentrations."

does that means that if I evaluated the first set of 6 batches on a linearity range narrower than it should be data will still accepted?

2- page E34 INCURRED SAMPLE RE-ANALYSIS
"the study sample results obtained for establishing incurred sample reportducibility may be used for comparison purposes, and do not necessarily have to be used in calculating reported sample concentration."

what does it mean????

3- page E 36 Source data documentation
"Modification of calibration response (deletion of individual standard points that exceed predefined acceptance limits or alteration of the standard curve range"

can I conclude that in my final study report I can delete some unaccepted points from my linearity range, and report it as (blank), ? what MODIFICATION means to u??

4- page E 37 STABILITY RECOMENDATIONS
"...intended (nominal) concentrations should be used..."

Why we dont report stability in absolute peak area, thus reporting in concentrations and comparing with nominal values will depend also on the sensitivity of the method and the interferance of slope variation will account then...

5- page E38 MATRIX EFFECTS FOR MS-BASED ASSAYS
"presence of matrix ions and absence of matrix ions"
does this means to u that comparision is done between spiked plasma samples and spiked mobile phase samples??


regards
charl