Project: kurup, Assay: assay 09:12:43, 28.03.

2011
Page 1 of 4

Results of Assay assay

Project kurup
PLA Database PLA 2.0 Default Database
Operator PLA Administrator
Computer System ID USER-PC
PLA Version 2.0.0 (build 550) (Trial Version)

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Date / Signature

Properties

Standard Unknown

General:
Name: standard preparation
Description: standard preparation
Measured substance / Batch ID: -/- -/-
Status declared hidden: no no
Measurement timestamp: 07:03:43, 28.03.2011 07:03:43, 28.03.2011
Object created by, time, date: PLA Administrator, 07:19:47, 28.03.2011 PLA Administrator, 07:26:08, 28.03.2011
Last modification by, time, date: PLA Administrator, 07:32:18, 28.03.2011 PLA Administrator, 07:30:54, 28.03.2011

Doses:
Raw Material activated: no no
Stock Solution activated: no no
Pre-Dilutiuon activated: no no
Number of treatments (dilution steps): 3 3
Number of replicates: 6 6
Dilution scale: 1:2 1:2

Analysis:
Model: - Parallel-line model - linear response
Invert potency ratio: - no
Outlier detection: none none
Hypothesis testing: - ANOVA based on pure error separation
Significance of slope, reject if failed: - 99.5%, yes
Significance of non-linearity, reject if failed: - 99.5%, yes
Test for parallelism: - Hypothesis Test (F-Test) for significant
deviations from parallelism
Significance of non-parallelism, reject if - 95.0%, yes
failed:
Confidence interval for potency estimation: - 95.0%
Confidence interval accord. to Fieller: - yes
EC50 calculation: Not estimated Not estimated

Configuration:
Linear detection type Full Range Full Range

GxP:
Administrative GxP protection activated: no no
User level GxP protection activated: no no

PLA 2.0.0 (build 550) is a product of Stegmann Systems, Germany • www.bioassay.de

Project: kurup, Assay: assay 09:12:43, 28.03.2011
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Data Values
Response values in bold are used for analysis as a result of your configuration.

Unknown: preparation

Dose Values 1.0 0.5 0.25

Response 1 200.0 165.0 120.0

2 195.0 170.0 115.0
3 205.0 160.0 120.0
4 200.0 165.0 125.0
5 210.0 165.0 135.0
6 205.0 165.0 135.0

Mean 202.500 165.000 125.000

SD 5.244 3.162 8.367
CV [%] 2.590 1.917 6.693

50% Response: 163.750

Standard: standard

Dose Values 1.0 0.5 0.25

Response 1 195.0 165.0 125.0

2 195.0 160.0 115.0
3 215.0 165.0 110.0
4 220.0 170.0 135.0
5 210.0 155.0 140.0
6 190.0 165.0 120.0

Mean 204.167 163.333 124.167

SD 12.416 5.164 11.583
CV [%] 6.081 3.162 9.329

50% Response: 164.167

PLA 2.0.0 (build 550) is a product of Stegmann Systems, Germany • www.bioassay.de

Project: kurup, Assay: assay 09:12:43, 28.03.2011
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Results
Analysis of variance (ANOVA)
Total number of observations: 36
Source of Variation d.f. Sum of Squares Mean Squares F-Ratio Probability

Treatments 5 37228.472 7445.694

Preparation 1 0.694 0.694
Regression 1 37209.375 37209.375 528.417 1.329 E-020
Non-Parallelism 1 9.375 9.375 0.133 0.718
Non-Linearity (LoF) 2 9.028 4.514 0.064 0.938
Residual (Pure) Error 30 2112.500 70.417
Total 35 39340.972 1124.028

Regression

Restricted Model (Common Slope)

Parameter Estimate Error Quality of Regression

Intercept Unknown 203.542 2.616 r² 0.998

Intercept Standard 203.264 2.616 g 0.008
Common slope 39.375 1.713 λ 0.213

Unrestricted Model (Different Slopes)

Parameter Estimate Error Quality of Regression

Intercept Unknown 202.917 3.127 r² 0.998

Intercept Standard 203.889 3.127 Ratio of Slopes 0.969
Slope Unknown 38.750 2.422
Slope Standard 40.000 2.422

Tests of Validity

Test of Regression (F-Test)

FRegression 528.417 This test passes if FRegression > Fcritical

Fcritical (99.5%) 9.180 Test Passed!

Test of Linearity (F-Test)

Fnon-linearity 0.064 This test passes if Fnon-linearity < Fcritical

Fcritical (99.5%) 6.355 Test Passed!

Test of Parallelism (F-Test)

Fnon-parallelism 0.133 This test passes if Fnon-parallelism < Fcritical

Fcritical (95.0%) 4.171 Test Passed!

PLA 2.0.0 (build 550) is a product of Stegmann Systems, Germany • www.bioassay.de

Project: kurup, Assay: assay 09:12:43, 28.03.2011
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Potency Estimation

preparation vs. standard

Potency Ratio (without Pre-Dilution Factors) 1.005

95.0% Confidence Interval 0.908 - 1.112
Relative Confidence Interval 90.4% - 110.6% (20.2%)

Graphics
Mean Graph Unrestricted Model Restricted Model

PLA 2.0.0 (build 550) is a product of Stegmann Systems, Germany • www.bioassay.de