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 the most basic sense, relative potency bioassays consist of a comparison of the behaviour of a reference standard to that of a test sample. That process is not... read more →
Picture the scene. You’re busily developing your assay and its data fits your chosen 4PL model beautifully. You’re just about to move onto validation—everything’s going so well!—but, out... read more →
Relative. Thanks for reading…But wait a moment! Have you ever stopped to ask why relative potency (RP) assays are the most common potency assay? Perhaps there are cases where... read more →
Interim analyses are common in medical device trials for a variety of reasons. Just having a look is fine, but if the outcome of the analysis could change the conduct... read more →