Five-dose multiple assay with completely …

1 Europ. Pharm., 5th Ed. (2005), Ch. , - Five-dose multiple assay with completely randomised design - An in-vitroassay of three hepatitis B vaccines against a standardPage 1 of 7 Document-22 (PLA Customer Support)DOCUMENT-2283D38D90-634B-4DC2-AC 0B-15697A1768D2 Report generated: 12:09:31 PLA (build 623) is a product of Stegmann Systems, Germany Pharm., 5th Ed. (2005), Ch. , - Five-dose multipleassay with completely randomised design - An in-vitro assay ofthree hepatitis B vaccines against a standardDocument-Id:Document-22 (Revision:2)Document Type:Quantitative Response assay /14 Last 12:09:16 Database:PLA Customer SupportDatabase GUID:83d38d90-634b-4dc2-ac0b-15697a1768d 2 CalculationCalculation 12:09:16, Matthias Schmitt (PLA Build 623, nbmsc03, 10014)Report 12:09:31, Matthias Schmitt (PLA Build 623, nbmsc03, 10014)CommentsComment by Matthias Schmitt: ( 12:16:18)European Pharmacopoeia, 5th Edition (2005), Chapter Five-dose multiple assay with completely randomised design - An in-vitro assay of three hepatitis B vaccines against a standardRemarks: Multiplex analysisSignaturesResponsibilityApproval ReviewEurop.

2 Pharm., 5th Ed. (2005), Ch. , - Five-dose multiple assay with completely randomised design - An in-vitroassay of three hepatitis B vaccines against a standardPage 2 of 7 Document-22 (PLA Customer Support)Report generated: 12:09:31 PLA (build 623) is a product of Stegmann Systems, Germany PropertiesAnalysisGeneralResponse AdjustmentNoneResponse TransformationLogarithmicModelLinear ModelMultiplex AssayYesPotency Estimation Confidence mean potency estimate of test samplesNoANOVA ModelANOVA (Pure Error Separation)ANOVA with consideration of additional factorsYesLogarithm BaseNatural logarithm (base e)Invert 11:26:42 Europ. Pharm., 5th Ed. (2005), Ch. , - Five-dose multiple assay with completely randomised design - An in-vitroassay of three hepatitis B vaccines against a standardPage 3 of 7 Document-22 (PLA Customer Support)Report generated: 12:09:31 PLA (build 623) is a product of Stegmann Systems, Germany SetupSetupStandard Sample: STest Sample: TTest Sample: UPreparation SchemePreparationScheme-1 PreparationScheme-1 PreparationScheme-1 Step Count555 Replicate Count333 Potency DefinitionBy Stock SolutionBy Stock SolutionBy Stock SolutionAssigned Assumed Potency20 g protein/ml20 g protein/ml20 g protein/mlDilution Scalen-Fold Sequencen-Fold Sequencen-Fold Sample: STest Sample: TTest Sample.

3 UData Selection SchemeDataSelectionScheme-1 DataSelectionScheme-1 DataSelectionScheme-1 Outlier DetectionNoneNoneNoneRangeFullFullFullOp timizationNoNoNoSetupTest Sample: VPreparation SchemePreparationScheme-1 Step Count5 Replicate Count3 Potency DefinitionBy Stock SolutionAssigned Assumed Potency20 g protein/mlDilution Scalen-Fold Sample: VData Selection SchemeDataSelectionScheme-1 Outlier DetectionNoneRangeFullOptimizationNoObse rvationsResponse values in bold are used for analysis as a result of your Sample: SSelected Steps: 1, 2, 3, 4, 5 dose [%] Pharm., 5th Ed. (2005), Ch. , - Five-dose multiple assay with completely randomised design - An in-vitroassay of three hepatitis B vaccines against a standardPage 4 of 7 Document-22 (PLA Customer Support)Report generated: 12:09:31 PLA (build 623) is a product of Stegmann Systems, Germany Sample: TSelected Steps: 1, 2, 3, 4, 5 dose [%] Sample: USelected Steps: 1, 2, 3, 4, 5 dose [%] Sample: VSelected Steps: 1, 2, 3, 4, 5 dose [%] Pharm.

4 , 5th Ed. (2005), Ch. , - Five-dose multiple assay with completely randomised design - An in-vitroassay of three hepatitis B vaccines against a standardPage 5 of 7 Document-22 (PLA Customer Support)Report generated: 12:09:31 PLA (build 623) is a product of Stegmann Systems, Germany of Variance (ANOVA)Total number of observations: 60 Source of of SquaresMean (LoF) (Pure) Model (Common Slope and Asymptotes)ParameterEstimateErrorQuality of RegressionS RegressionParameterEstimateErrorQuality of RegressionS Pharm., 5th Ed. (2005), Ch. , - Five-dose multiple assay with completely randomised design - An in-vitroassay of three hepatitis B vaccines against a standardPage 6 of 7 Document-22 (PLA Customer Support)Report generated: 12:09:31 PLA (build 623) is a product of Stegmann Systems, Germany TestsOverview:PassedFailed (Rejected)Failed (Warning)Passed (Info)Not CalculatedAssay Suitability00000 Sample Suitability20000 Overall Test ResultPassedSample Suitability TestsF-Test (Hypothesis Test): Significance of Non-LinearityS, T, U, VTest SeverityF critical( ) (Hypothesis Test): Significance of Non-ParallelismS, T, U, VTest SeverityF critical( ) Pharm.

5 , 5th Ed. (2005), Ch. , - Five-dose multiple assay with completely randomised design - An in-vitroassay of three hepatitis B vaccines against a standardPage 7 of 7 Document-22 (PLA Customer Support)Report generated: 12:09:31 PLA (build 623) is a product of Stegmann Systems, Germany EstimationRelative PotencyTSPotency Confidence - Confidence - ( )Stock SolutionAssumed/Assigned g g protein/mlFactor rel. Estimated Sample Sample Potency (Stock Solution) g protein/ml95% Confidence - g protein/mlRelative Confidence - ( )Relative PotencyUSPotency Confidence - Confidence - ( )Stock SolutionAssumed/Assigned g g protein/mlFactor rel. Estimated Sample Sample Potency (Stock Solution) g protein/ml95% Confidence - g protein/mlRelative Confidence - ( )Relative PotencyVSPotency Confidence - Confidence - ( )Stock SolutionAssumed/Assigned g g protein/mlFactor rel.

6 Estimated Sample Sample Potency (Stock Solution) g protein/ml95% Confidence - g protein/mlRelative Confidence - ( )Graphics