Bioequivalence and Bioavailability Forum

Dear Auditor,

In repeat analysis under aberrant value is always a ???. For this till no accepted guidelines or suggestions to be published for analysis of repeat under aberrant value.

In your case, I suggest,

1. If you're analytical method is simultaneous, and only one analyte showing aberrant value and remaining is not identified, so it was not be consider as a aberrant value because your sample collection and analysis procedure is same for both the analyte.
   
2. The aberrant value observed in initial two time point which concentration is near to your LOQ QC, so it not to be aberrant, at lower concentration these may happen due to revesible/irrevsible metabolism by CYP process in Parent to Metabolite conversion .
   
3. For Aberrant value identification, required to define procedure in the internal Repeat SOP, with considering appropriate criteria to compare of aberrant value with respect to its two adjacent Preceding and succeeding value in a similar way.

Regards,

Keshav D.Khude

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! Please check the spelling of your messages before posting them - your post is rather difficult to comprehend; see also this post. [Jaime]