Quantics provides best practice bioassay statistics, and is a
key opinion leader in this developing field. We're involved with
guideline development and discussions with the US Pharmacopeia
(USP).
Bioassay validation is essential for any biologic. Quantics
will help you get the most from your experimental data, reducing
time, costs and risk for investors.
Assay and potency testing of biologics requires unique
experimental designs and analysis. Optimising these factors
can reduce batch rejection, animal or tissue usage, and increase
product reliability. However the statistics involved are complex
and not yet fully defined in guidelines. Quantics is involved in
the methodology development and can ensure you are using the best
available, regulatory compliant experimental design and
analysis.
As a result of our experience as bioassay statistical consultants,
Quantics Consulting were invited speakers at the US Pharmacopeia
Bioassay Workshop, August 2010.