pla (version 0.2)

Turbidimetric: Antibiotic turbidimetric assay

Description

5.1.3. FOUR-DOSE RANDOMIZED BLOCK DESIGN

Usage

data("Turbidimetric")

Source

The example can also be found at CombiStats - EDQM, Council of Europe (http://combistats.edqm.eu): http://combistats.edqm.eu/content/view/188/199/

Details

From Ph.Eur.: This assay is designed to assign a potency in international units per vial. The standard has an assigned potency of 670 IU/mg. The test preparation has an assumed potency of 20 000 IU/vial. On the basis of this information the stock solutions are prepared as follows. 16.7 mg of the standard is dissolved in 25 ml solvent and the contents of one vial of the test preparation are dissolved in 40 ml solvent. The final solutions are prepared by first diluting to 1/40 and further using a dilution ratio of 1.5. The tubes are placed in a water-bath in a randomized block arrangement (see Section 8.5). The responses are listed in Table 5.1.3.-I. Inspection of Figure 5.1.3.-I gives no rise to doubt the validity of the assumptions of normality and homogeneity of variance of the data. The standard deviation of S3 is somewhat high but is no reason for concern.

References

Chapter 5.3. Statistical analysis. In EUROPEAN PHARMACOPOEIA version 8.0, 2014; 607-635.

Examples

data(Turbidimetric); Data <- Turbidimetric

Data <- readAssayTable(paste(system.file(package = "pla"),
                             "vignettes/PhEur/data/AntibioticTurbidimetric.txt",
                             sep = "/"))
plaModel <- plaRBD(Data,
                   assayTitle = "PhEur: Antibiotic turbidimetric assay")
plaModel
plots    <- plot(plaModel)