- On 19 Aug 2005 at 12:36:30, "Katya Tsaioun" (ktsaioun.at.Nitromed.com) sent the message

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Does anyone have a good basic reference on how did polynominal fit for

calibration curves became acceptable? - On 19 Aug 2005 at 14:08:26, "Frank Bales" (frankbales.-at-.msn.com) sent the message

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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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