Canned Calculation for ICH Guideline M10 – 3.2.4/3.3.2 Calibration Standard Accuracy Available for SCIEX OS Software

For research use only. Not for use in diagnostic procedures.

Issue Description

SCIEX provides pre-assembled calculation packages ('Canned Calculations') for use with processing methods created in SCIEX OS software for several common application workflows. These calculation packages can be used with SCIEX OS software version 2.2 and higher (depending on the used software features) and contain the custom calculations and flagging rules needed to process data for a commonly-used application, such as the technical guidance on bioanalytical method validation and study sample analysis ICH guideline M10.

This article provides information on the custom calculations required for processing data according to the guidance found in analysis ICH guideline M10 – 3.2.4 and 3.3.2:
‘The back-calculated concentrations of the calibration standards should be within ±15% of the nominal value, except for the LLOQ for which it should be within ±20%. At least 75% of the calibration standard concentrations, which should include a minimum of six concentration levels, should fulfil these criteria.’
 

Resolution

Resolution
The idea behind Canned Calculations for SCIEX OS software is to provide a ready-to-go, user friendly, data processing solution containing all the calculations and flagging rules that can be imported into a results table created in the Analytics workspace.
The calculations do provide a plug-and-play approach, but the resulting custom columns in the results table require some additional interpretation after applying the calculations. Each calculation in the package should be evaluated and adjusted to suit each lab's needs, they should apply their own insights when interpreting method guidelines, when identifying the samples used for the calculations, when presenting the results and when linking different calculations.


Sample sets processed using the ICH M10 guidance must be evaluated to ensure, that the back-calculated concentrations of the calibration standards are within ±15% of the nominal value, except for the LLOQ for which it should be within ±20% and that at least 75% of the calibration standard concentrations, which should include a minimum of six concentration levels, should fulfil these criteria. To automate this, SCIEX generated a set of calculations and flagging rules that provide custom columns indicating if a sample should be flagged or not. The example result table below shows custom columns, generated with the canned calculations using a default data set (‘Documentation and sample data’), that is available when you are logged in on our website at this link in 'SCIEX OS Resources':
https://sciex.com/support/software-support/software-downloads

Requests to obtain the canned calculation package for ICH M10 – 3.2.4/3.3.2 Calibration Standard Accuracy can be made by opening a case with SCIEXNow and referencing this article.