{"id":2357,"date":"2022-05-18T17:40:53","date_gmt":"2022-05-18T17:40:53","guid":{"rendered":"https:\/\/admin.acceleratingscience.com\/connectedlab\/?p=2357"},"modified":"2025-01-06T14:15:03","modified_gmt":"2025-01-06T14:15:03","slug":"using-watson-lims-for-internal-standard-response-review","status":"publish","type":"post","link":"https:\/\/www.thermofisher.com\/blog\/connectedlab\/using-watson-lims-for-internal-standard-response-review\/","title":{"rendered":"Using Watson LIMS for Internal Standard Response Review"},"content":{"rendered":"

Thermo Scientific\u2122 Watson LIMS\u2122 software version 7.7 introduces a dedicated Internal Standard (IS) response review workflow. IS response review aims to reduce the risk of over- or under-reporting final concentration data based on anomalous internal standard peak area. The new capabilities align with the U.S. Food and Drug Administration (FDA) guidance \u201cEvaluation of Internal Standard Responses during Chromatographic Bioanalysis<\/a>.\u201d\u00a0 Here, we examine IS response review and how Watson LIMS supports IS review best practices.<\/p>\n

\"Watson

Using Watson LIMS for Internal Standard Response Review.<\/p><\/div>\n

What is IS Response?<\/h2>\n

The FDA guidance<\/a> document defines IS response as a measurement of the signal from the IS, which is typically generated during liquid chromatography-mass spectrometry bioanalysis. In analytical chemistry, ISs are usually a structural analog or stable isotope of an analyte of interest and are commonly used in chromatographic analytical methods to correct for variability in sample processing and analysis.<\/p>\n

A known IS quantity is added to all samples, including quality controls (QCs), calibration standards (Cals), and study samples prior to sample prep. The specific IS selected for a method should have similar properties to the analyte of interest so that it tracks to any changes within the analyte measurement that may occur during sample processing and data acquisition.<\/p>\n

The FDA guidance document provides recommendations to sponsors, applicants, and contract research organizations regarding IS response variability in chromatographic analytical data submitted in investigational new drug applications, new drug applications, abbreviated new drug applications, biologics license applications, and supplements. The document provides the Agency\u2019s current thinking on IS response variability and its potential impact on the accuracy of analyte concentration measurements.<\/p>\n

Using Watson for IS Response Review<\/h2>\n

The IS review capabilities in Watson LIMS version 7.7 are aligned with industry best practices. The new capabilities are designed with feedback from customers performing IS review using chromatography software.<\/p>\n

In defining the new workflow, the team observed that users will often define criteria a priori<\/em> such that users can review and identify individual outliers or systemic trends – thereby reducing the risk of reporting inaccurate concentration data impacted by anomalous IS response. To meet this requirement, Watson LIMS enables users to define criteria upfront. Users can select from three different methods, with different sample types to select that will comprise the reference point. Each IS within the assay can store its own criteria, in case there is a mix of stable-labeled and analog ISs. Since not all labs employ an SOP governing IS review, Watson LIMS also enables users to bypass the IS definition and move directly into the visualization tools.<\/p>\n

\"Establish

Establish IS criteria.<\/p><\/div>\n

New visualization tools are provided to review IS response. <\/strong>Highlights include:<\/p>\n