Sample Statistics and Analyses for Immunogenicity ELISA

• Calculation of titers
• Qualification criteria for positive, negative, and naïve controls
• Qualification criteria of treatment optical density and titer values
• Estimation of titer values using model fitting (e.g., 4-parameter logistic)
• Calculation of dose-response relationship, including parameter estimates for the dose-response model (e.g., 4-paramter logistic, Michaelis-Menten)
• Statistical comparisons among lots and/or over time