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).

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