Quantics can help ensure that your bioassay validation study follows the appropriate regulatory guidance in all its statistical aspects, both design and analysis.

Our expert team of world-leading statisticians are well-equipped to assist with the design and analysis of any bioassay validation study. We can help you determine critical bioassay validation parameters including:

  • Relative Bias (Accuracy)
  • Intermediate Precision (Precision)
  • Assay Range
  • Specificity
  • Dilutional Linearity
  • Robustness
  • & More

We know that bioassay validation can be complicated, which is why we pride ourselves on clear and regular communication with our clients, both to determine client needs and to discuss results and next steps.

Image credit:  https://www.usp.org/

Validation of Bioassays

Bioassay validation is the process of demonstrating and documenting that the performance characteristics of the procedure and its underlying method meet the requirements for the intended application and that the assay is thereby suitable for its intended use.

Read our blog about upcoming updates to USP <1033>

Get in Touch!

Need bioequivalence statistics? Use the form below to book a 30 Minute discovery call with our Customer Experience Manager, Andy Rust (andy.rust@quantics.co.uk).

Or, visit our enquiries page:

Contact Us!

Follow our Bioassay Blog!

Sep 17

Making the most of your bioassay control wells

The control: a vital part of any scientific experiment. The only way to establish causality between the dependent and independent variables in an experiment is by comparison with a control. Controls are also important for establishing detection background: what does “nothing” look like on your sensor? Bioassays are no... read more →
Aug 06

What is the 5PL Formula?

In bioassay analyses, there are three statistical models that are commonly fit to dose-response data: the linear model, the 4PL model, and the 5PL model. We’ve examined the properties of the 4PL model in great detail previously, and the time has come to give the 5PL model a similar... read more →
Jun 27

ELISA Bioanalysis: Key Advantages of the BY Method

Enzyme-Linked Immunosorbent Assays (ELISA) are a key tool for determining concentrations, forming a key component of many fields in the life sciences. From testing food products for allergens to detecting HIV in a patient’s blood and beyond, ELISA analysis is a vital component of a scientist’s arsenal. Quantics has... read more →