Support Regulatory

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:

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Follow our Bioassay Blog!

Apr 22

USP 1033: A Validation Example

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 and precision. Then, we discussed Probability of Out-of-Specification (Prob(OOS)) and how this can be used to inform the acceptance criteria... read more →
Feb 25

USP 1033: Bioassay Validation Acceptance Criteria

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... read more →
Feb 11