Immunogenicity and Setting Cut Points

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Biological vs. Analytical96 96 94 9695 96 93 9696 96 94 9685 86 96 94 96 94 96 96 96 94 96 95 96 94 96 96 94 96 97 96 94 9684 86 95 95 96 95 96 96 97 93 95 95 96 93 97 96 95 96 96 96 95 9785 86 96 94 96 94 96 96 96 94 96 95 83 82 96 96 94 96 97 96 94 9616
Balanced Design for ValidationExperiments51 drug naïve ADA negative sample6 runs, 2 analysts (3 runs per analyst)Each sample tested in DuplicateReportable result:• Average of the duplicate* samplesNegative sample, Low VC, High VC; > 2results/plate, each in duplicate*Three plates used per Run for testing thesesamples.Include drug-spiked samples as well for confirmation cut point.Precision, Confirmation CP, can also be evaluated from thisexperiment.17
Page 1 and 2: Immunogenicity and SettingCut Point
Page 3 and 4: Screening Cut Point• Definition:
Page 8 and 9: But 5% of the time we hit something
Page 11 and 12: Upper BalconiesHigh PCMiddle Balcon
Page 13 and 14: Upper BalconiesHigh PCMiddle Balcon
Page 15: Assay Background has 2 VariationCom
Page 19 and 20: Balanced Design - includesinhibitor
Page 21 and 22: Types of Screening Cut Points• Fi
Page 23 and 24: Types of Screening Cut Points• Dy
Page 25 and 26: Screening CP Evaluation Flow-Scheme
Page 27 and 28: Distribution & OutliersOriginal Dat
Page 29 and 30: Distribution and OutliersRun 1 Log
Page 31 and 32: How the SD should be calculate?•
Page 33 and 34: Fixed or Floating?Log OD-1-21 2 3 4
Page 35 and 36: Floating Cut PointAdditive or Multi
Page 37 and 38: Switches and Balls• The specific
Page 39 and 40: Non-specific inhibition asrepresent
Page 41 and 42: Setting LimitsLowPositiveControlLar
Page 43 and 44: Confirmation Cut PointexampleIndivi
Page 45 and 46: Confirmation Cut PointexampleAll Da
Page 47 and 48: Acknowledgements• Wendell Smith,

Immunogenicity and Setting Cut Points

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