The accuracy of reported sample results is contingent upon the quality of the assay calibration
curve, and as such, calibration curves are critical components of ligand binding and other …

Since the adoption of the ICH Q8 document concerning the development of pharmaceutical
processes following a quality by design (QbD) approach, there have been many discussions …

Quality controls (QCs) are the primary indices of assay performance and an important tool in
assay lifecycle management. Inclusion of QCs in the testing process allows for the detection …

Purpose The study aimed to develop a motion capture system that can track, visualize, and
analyze the entire performance of self-injection with the auto-injector. Methods Each of nine …

The use of Bayesian methods to support pharmaceutical product development has grown in
recent years. In clinical statistics, the drive to provide faster access for patients to medical …

Optimizing a formulation buffer for biological products such as vaccines or monoclonal
antibodies is a complex task. One of the reasons for this is that the number of formulation …

Potency bioassays are used to measure biological activity. Consequently, potency is considered
a critical quality attribute in manufacturing. Relative potency is measured by comparing …

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 contrasts …

Parallelism testing between two four-parameter logistic curves has been widely discussed
over the last decade. Current tests available in common statistical software used in …