Bioassay data analysis is used to determine the potency of protein therapeutics. To properly
determine potency, the experimental data need to be fitted to a model that adequately …

The appropriate validation of analytical methods has become an essential part of successful
drug development and characterization. Validation of a method involves using experimental …

“Because of the inherent variability in biological test systems (including that from animals,
cells, instruments, reagents, and day-to-day and between-lab), an absolute measure of …

Relative potency assays for biological therapeutics require statistical evaluation to
demonstrate similarity between the dose–response curves of a reference standard and the …

Biological assays (bioassays) are procedures to estimate the potency of a substance by
studying its effects on living organisms, tissues, and cells. Bioassays are essential tools for …

The role of biotherapeutic proteins in the prevention and treatment of diseases such as
cancers, infectious diseases, and autoimmune disorders continues to grow. The biological …

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 USP< 1032> guidelines recommend the screening of bioassay data for outliers prior to
performing a relative potency (RP) analysis. The guidelines, however, do not offer advice on …

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 …

For most biopharmaceuticals, potency is assessed in a bioassay by comparing dose–
response curves of the test material and a reference standard. As with all analytical …