Module 9 2024

03/09/2024

Assay Design & Stats Analysis

Guidance docs:

Design and Development of Biological Assays

provides very descriptive and statistically comprehensive advice for developers

ICH Q6B - high level guidance

The Organisation for Professionals in Regulatory Affairs

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Assay Design & Stats Analysis

Common assay characteristics

96 well plate platform – most common • Miniaturisation to 384 plates – on the increase, offers more sampling options and designs. Common assay challenges • Row, column positional effects • Variation plate loading in assay – row A always first? • How long incubation steps at 37 o C (>18 hr) • Can lead to different responses from centre wells Resolutions • Alter/randomise plate layout to mitigate positional bias • Use inner 60 wells, protected by outer wells filled with culture medium. A H 1

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The Organisation for Professionals in Regulatory Affairs

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