Assay elements
In PLA 3.0, assay elements are the building blocks of assay documents. By default, Cylinder plate assay (USP <81>) documents contain one assay element for the reference standard and one assay element for the test sample.
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Standard
The Standard element defines the reference standard of the assay document. The standard provides a series of measurements at two or more concentrations. Calculations performed with the assay document determine potencies of test samples in comparison to the reference standard.
Test
Each Test element defines a test sample of the assay document. Each test sample provides a series of measurements at one concentration. Calculations performed with the assay document determine the potencies of the test samples.
Control
Each Control element defines a control of the assay document. Each control provides a series of measurements at a single concentration. You can use controls in the test system and in response data processing steps (adjustments and normalizations).
Observation group ID
Observation groups link individual observations (measurements, data table rows) to their assay elements (samples). Each observation group consists of the observations of a single assay element.
Each assay element has a unique observation group ID assigned, linking the assay element to its respective observation data in the data editors. To switch plate positions for your samples, simply reassign the respective assay elements to a different observation group ID.
The Maximal group number setting in the observation data of the Content editor limits the number of observation groups (assay elements) for which the Observations editor can display data. If your assay document has more assay elements, you need to change the setting according to your requirements.
In the data table of the Observations editor, the observation group ID displays both the observation group ID and the assay element name for each observation.