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So far I have only a handfull of responses. Please take a minute to
review and complete the following. Add comments as needed:
This only applies to Bioanalytical method validation
1) When running accuracy and precison experiments do you use:
Fresh curves and Fresh QC (Y) (N)
Frozen Curves and Frozen QC (Y) (N)
2) When assessing stability of QC do you use:
Fresh Curves, Fresh QCs for plate acceptance (Y) (N)
Fresh Curves, Frozen QC for plate acceptance (Y) (N)
Frozen Curves, Frozen QC for plate acceptance (Y) (N)
3) When running production/sample analyses do you use
Fresh Curves, Fresh QCs for plate acceptance (Y) (N)
Fresh Curves, Frozen QC for plate acceptance (Y) (N)
Frozen Curves, Frozen QC for plate acceptance (Y) (N)
4) When examing a method for the presence of a hook effect
Do you extend the curve from the ULOQ up 6 to 10 levels,
using the same dilution factors employed in the standard curve?
or do you start with the estimated cMax and work down?
I am particularly interested in the concept that because the samples
are frozen, we need only concern ourselves with frozen curves and qc
and need not necessarily be concerned with differences between fresh
(day of use) materials and frozen. Please comment. Remember that
the tox, PK and PD will reference the concentrations reported.
Would not the PK scientists need at least an understanding of how
freezing may affect apparent analyte concentration? Need to hear
from you. Thanks in advance.
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Dear Mr. Connor
1) When running accuracy and precison experiments do you use:
Fresh curves and Fresh QC (N)
Frozen Curves and Frozen QC (Y)
2) When assessing stability of QC do you use:
Fresh Curves, Fresh QCs for plate acceptance (Y) (N)
Fresh Curves, Frozen QC for plate acceptance (Y) (N)
Frozen Curves, Frozen QC for plate acceptance (Y) (N)
none of above -we use frozen curve and fresh QC
3) When running production/sample analyses do you use
Fresh Curves, Fresh QCs for plate acceptance (N)
Fresh Curves, Frozen QC for plate acceptance (N)
Frozen Curves, Frozen QC for plate acceptance (Y)
4) When examing a method for the presence of a hook effect
Do you extend the curve from the ULOQ up 6 to 10 levels,
using the same dilution factors employed in the standard curve?
or do you start with the estimated cMax and work down?
my query- what is HOOK EFFECT??
Abhijith Rao
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