Immunogenicity and Setting Cut Points

More documents

Recommendations

Info

Floating Cut PointAdditive or Multiplicative Correction Factor?• When floating CP is used, need to determine acorrection factor (CF)• Let• CP.V= Cut point from validation data• NC.V= Negative Control from validation experiment• NC.IS=Negative Control for in-study run• If untransformed i.e. normal and & CP analysiswas done on untransformed data,• CP.V-NC.V=CF• Floating CP= NC.IS+CFRemember Untransformed use Additive34
Floating Cut PointAdditive or Multiplicative Correction Factor?If only the log transformed data i.e. normal and CPanalysis was done on a log scale,log (CF) = log(CP.V) – log (NC.V)CF = CP.V / NC.VFloating CP – NC.IS * CFRemember if transformed CV use Multiplication.35
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: Fixed or Floating?Log OD-1-21 2 3 4
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

Create successful ePaper yourself

Delete template?

Save as template?