EXCEL Program for Computation of Accuracy / Precision Summary Statistics
for Pre-Study Methods Validation

The attached program was written, validated and made available by P&G Pharmaceuticals.  The program performs computation of Accuracy and Precision summary statistics as outlined in the manuscript by DeSilva et al., titled Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules,in Pharmaceutical Research [vol 20(11): 1885-1900 (2003)].  The calculated estimates of precision and accuracy for each Pre-Study validation (QC) sample are obtained using formulae for an analysis of variance (ANOVA) based on the one-factor random effects model.  

A few features of this program include computation of a ‘pooled’ estimate for intra-assay imprecision (repeatability), estimation of ‘total random error’ as inter-assay imprecision (intermediate precision), and use of nominal values for computing the %CV.  In addition to reporting the lower and upper confidence limits for the mean bias, the summary report includes the 90% Expectation Tolerance Interval which is useful for predicting future results for In-Study QC samples. The program is limited to 6 assay runs and 10 replicates per run.

Please download the following three files and save to your hard drive:

Installation and Usage Instructions.pdf (Read this first)

LBA.exe (Self-extracting files necessary to run the LBA application)

LBA PDF Files.zip (Contains the validation related documentation to help modify and improve the application as needed for individual users.)  

For examples of the input and output files, see the pdf documents included in the Examples Folder.

Examples Folder:

Batch1.pdf
Batch2.pdf
Batch3.pdf
Batch4.pdf
Batch5.pdf
Batch6.pdf
LBA application results.pdf
LBA application sum_tbl.pdf

Disclaimer:

This software was developed and validated at Procter & Gamble Pharmaceuticals and is being made available free of charge to the scientific community through AAPS. It is not intended for sale or use for any commercial purposes.  Neither Procter & Gamble Pharmaceuticals nor AAPS assume any liability for the use of the data generated using this program.  It is the responsibility of the user to ensure that the software is appropriate for his/her application and to verify or validate the integrity of the data. Validation data provided in these files cannot be used by individual users for commercial purposes.