Europ. Pharm., 5th Ed. (2005), Ch. 5.3, A completely randomised (0,4,4,4)-design - An in-vitro assay of influenza vaccines
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1 Page 1 of 6 Europ. Pharm., 5th Ed. (2005), Ch. 5.3, A completely randomised (0,4,4,4)-design - An in-vitro assay of influenza Document-Id: Document-63 (Revision:3) Document Type: Quantitative Response Assay/14 Last Modified: :05:54 Database: PLA 3.0 Customer Support Database GUID: 83d38d90-634b-4dc2-ac0b-15697a1768d2 Calculation Calculation performed: :05:54, Matthias Schmitt (PLA Build 623, nbmsc03, 10014), Matthias Schmitt (PLA Build 623, nbmsc03, 10014) Signatures Responsibility Approval Review DOCUMENT-63 83D38D90-634B-4DC2-AC0B-15697A1768D2
2 Page 2 of 6 Overview General Properties Analysis General Response Adjustment None Response Transformation None Model Slope Ratio Multiplex Assay Yes Potency Estimation Confidence Interval 95.0% Calculate mean potency estimate of test samples No ANOVA Model ANOVA (Pure Error Separation) ANOVA with consideration of additional factors Yes Logarithm Base Natural logarithm (base e) Invert Potency No Documentation General Date :18:37
3 Page 3 of 6 Assay Setup Sample Setup Setup Standard Sample: Standard S Test Sample: Preparation T Test Sample: Preparation U Preparation Scheme PreparationScheme-1 PreparationScheme-1 PreparationScheme-1 Step Count Replicate Count Potency Definition By Stock Solution By Stock Solution By Stock Solution Assigned Assumed Potency 15 µg HA/ml 15 µg HA/ml 15 µg HA/ml Dilution Scale 7.5, 15, 22.5, , 15, 22.5, , 15, 22.5, 30 Analysis Standard Sample: Standard S Test Sample: Preparation T Test Sample: Preparation U Data Selection Scheme DataSelectionScheme-1 DataSelectionScheme-1 DataSelectionScheme-1 Outlier Detection None None None Range Full Full Full Optimization No No No Observations Response values in bold are used for analysis as a result of your configuration. Standard Sample: Standard S Selected Steps: 1, 2, 3, 4 Dose Value Dose Step Response Mean SD CV[%] Test Sample: Preparation T Selected Steps: 1, 2, 3, 4 Dose Value Dose Step Response Mean SD CV[%] Test Sample: Preparation U Selected Steps: 1, 2, 3, 4 Dose Value Dose Step Response Mean SD CV[%]
4 Page 4 of 6 Result Analysis of Variance (ANOVA) Total number of observations: 24 Source of Variation d.f. Sum of Squares Mean Squares F-Ratio Probability Treatments Regression E-12 Intersection Non-Linearity (LoF) Residual (Pure) Error Total Regression Restricted Model (Common Slope and Asymptotes) Parameter Estimate Error Quality of Regression Intercept Common Standard S Slope Common Preparation T Slope Common Preparation U Slope r² r² adjusted Unrestricted Regression Parameter Estimate Error Quality of Regression Standard S Intercept Standard S Slope Preparation T Intercept Preparation T Slope Preparation U Intercept Preparation U Slope r² r² adjusted
5 Page 5 of 6 Validity Tests Overview: Passed Failed (Rejected) Failed (Warning) Passed (Info) Not Calculated Assay Suitability Sample Suitability Overall Test Result Passed Sample Suitability Tests F-Test (Hypothesis Test): Significance of Non-Linearity Standard S, Preparation T, Preparation U Test Severity F critical(95.0%) F Test Sample Test: FTestNonSimilarity Standard S, Preparation T, Preparation U Test Severity F critical(95.0%) F Warning Warning Passed Passed
6 Page 6 of 6 Potency Estimation Relative Potency Preparation T Standard S Potency Ratio % Confidence Interval Relative Confidence Interval 93.54% % (13.31%) Stock Solution Assumed/Assigned Potency µg HA/ml µg HA/ml Factor rel. Estimated Sample Potency Estimated Sample Potency (Stock Solution) µg HA/ml 95% Confidence Interval µg HA/ml Relative Confidence Interval 93.54% % (13.31%) Relative Potency Preparation U Standard S Potency Ratio % Confidence Interval Relative Confidence Interval 91.00% % (18.03%) Stock Solution Assumed/Assigned Potency µg HA/ml µg HA/ml Factor rel. Estimated Sample Potency Estimated Sample Potency (Stock Solution) µg HA/ml 95% Confidence Interval µg HA/ml Relative Confidence Interval 91.00% % (18.03%) Graphics
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