Find details on the concepts that support you when setting up and working with
Equivalence margin development documents.
Note: This topic covers margin development for dose response assays. For details on quantitative response assays, see the Equivalence margin development topic.
Developing equivalence margins involves several key concepts that span over two editors.
The following figure illustrates these concepts and shows how they relate to the
workflow when setting up and working with Equivalence margin development documents.Figure 1. General workflow for developing equivalence margins for Dose-Response Analysis Package
Note: This workflow uses the default data table setup in the
Content editor, so it does not include settings for the
observation source or update mode. For details on these
settings, see the Observation source and Document references topics.
You begin in the References editor, where you select the source
assays and assign them as development or verification assays. For details, see the Development and verification assays topic.
From there, you continue in the Content editor, where you
configure core elements, including margin development, test strategies, and
visualization. For details, see the Margin development, Test strategies, and Visualization
topics
Tip: Once you finalized the development of your equivalence margins, create Test
system definition documents to export and reuse your test strategies. For details, see
the Export and reuse test strategies topic.