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The following message was posted to: PharmPK
Does anyone have a good basic reference on how did polynominal fit for
calibration curves became acceptable?
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The following message was posted to: PharmPK
Katya, regarding polynominal fit
Perhaps the following will help:
ICH Q2B states, "In some cases, to obtain linearity between assays
and sample concentrations, the test data may have to be subjected to
a mathematical transformation prior to the regression analysis".
Previous and current USP 28 S2 (and other similar documents) state,
"The linearity of an analytical method is its ability to elicit test
results that are directly, or by a well-defined mathematical
transformation, proportional to the concentration of analyte in
samples within a given range." "Well-defined" is usually taken to
mean a pre-established transformation. For example, a detector might
be known to produce results from the ratio of two inputs; or,
perhaps, in your case, a polynominal function.
Regards,
Frank Bales
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Copyright 1995-2010 David W. A. Bourne (david@boomer.org)