A validated bioassay is used to measure the potency of commercial lots, and as such, must
be accurate, precise, and fit for its intended purpose. Regulatory expectations for a bioassay …

This chapter shows that realistic, natural quality criteria may exist in complex quantitative
forms. The flexibility of the Bayesian approach nonetheless adapts in a straightforward …

A validated method is used to measure quality attributes of manufactured lots to support the
production of active ingredient or drug product for a regulatory filing or product release …

Recently, the lifecycle management concept for analytical procedures was introduced. It is
strongly related to the Quality by Design concept given in the ICH-Q8 guidance. This …

Biological activity is a critical quality attribute for biopharmaceuticals, which is accurately
measured using an appropriate relative potency bioassay. Developing a bioassay is a …

Drug discovery scientists routinely develop and use in-vitro assays; for example, to identify
“hits,” or to quantify the efficacious concentrations of compounds in a lead series. New and …

For biotherapeutics and vaccines, potency is measured in a bioassay that compares the
concentration-response curves of a new batch to that of a reference standard. Acceptable …

The August 2014 issue of Statistics in Biopharmaceutical Statistics (SBR) features a special
section on nonclinical statistical applications in biopharmaceutical research. A previous …

This chapter shows that analytical method or an assay can be developed following the best
practice of the industry—namely, the Analytical Quality by Design—to ensure a high …

The ICH Q2 (R1) Guidance on Validation of Analytical Procedures states that a robustness
assessment for an analytical method should provide “an indication of its reliability during …