Please turn JavaScript on
header-image

Quantics Biostatistics

We bring you the latest updates from Quantics Biostatistics through a simple and fast subscription.

We can deliver your news in your inbox, on your phone or you can read them here on this website on your personal news page.

Unsubscribe at any time without hassle.

Quantics Biostatistics's title: Quantics Biostatistics | A Leading Authority on Statistics in Life Sciences.

Is this your feed? Claim it!

Publisher:  Unclaimed!
Message frequency:  0.07 / day

Message History

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 to whether it will provide useful results – specifically whether the trial will have enough statistical power. Simultaneously, the cost and complexity of a trial can quickly escalate as the sample size inc...


Read full story

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 its intended use. Part of this demonstration is a detailed quantification of the accuracy and precision of the assay. We saw how accuracy and precision can be thought of conceptually, ...


Read full story

One can think of the life of a bioassay in two main acts. First comes the design and development of the assay, where the assay method is conceptualised, refined, and optimised. Later, the goal is for the assay to be deployed in a regulated environment to, for example, test batches of product to ensure that only those which meet the required specifications ar...


Read full story

One common use for bioassays is to test manufactured biologic products before they are released to the wider consumer market. While all bioassays used for this purpose will have undergone stringent testing and validation, it is vital that their ongoing performance is closely monitored to ensure that any changes in the assay system do not lead to incorrect de...


Read full story