The development of a bioassay is, in essence, a long series of choices. An assay which reaches commercial use is the end of a single path through a near-infinite... read more →
In the previous parts of our series covering the latest draft version of USP <1033>, we examined the goals of a bioassay validation study and the basics of accuracy... read more →
A key decision in the planning of a clinical trial is that of the sample size. As we’ve discussed previously, the number of participants in a trial is key... read more →
In the first part of our series examining USP <1033> in depth, we discussed the goals of bioassay validation – specifically, to demonstrate that an assay is suitable for... read more →
During the early development of many therapeutic products, analytical and data management processes are often created quickly and pragmatically. Excel spreadsheets, macros, and bespoke code are widely used because... read more →