Validation of statistical software is required for use in regulatory work. Many auditors expect to see the traditional IQ, OQ, PQ approach applied to the base system (SAS, R,... read more →
A common discussion we at Quantics have with our clients surrounds the issue of pseudo-replicates. It’s an area of tension between scientist and statistician – pseudo-replicates reduce the cost... read more →
The United States Pharmacopeia (USP) guidance on biological assay validation, General Chapter <1033>, will soon be updated. In the leadup to the publication of the new guidance,... read more →
In part 1 of our series covering the confidence interval, we examined some of the basic statistical concepts associated with a bioassay. In particular, we saw that a... read more →