Immunogenicity and Setting Cut Points

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Confirmation <strong>Cut</strong> PointexampleWith five sample excluded as outlierslog of ratioQuantilesCP-0.15 -0.1 -0.05 0 0.05Normal(-0.0509,0.0498)Shapiro-Wilk W TestW0.98904799(%inhibiti100*Prob
Acknowledgements• Wendell Smith, Ph.D. from B 2 S• Ron Bowsher, Ph.D. from B 2 S• Viswanath Devanarayan, Ph.D. from Abbot• The LBABFG of AAPS:Which included the immunogenicity sub-groupwhich authored the current “validation” whitepaper.Gopi Shankar, Viswanath Devanarayan, LakshmiAmaravadi, Yu Chen Barrett, Ronald Bowsher, DeborahFinco-Kent, Michele Fiscella, Boris Gorovits, SusanKirschner, Michael Moxness, Thomas Parish, ValerieQuarmby, Holly Smith, Wendell Smith, Linda A.Zuckerman <strong>and</strong> Eugen Koren47
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 and 16: Assay Background has 2 VariationCom
Page 17 and 18: Balanced Design for ValidationExper
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: Confirmation Cut PointexampleAll Da

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