Methods We used an anonymous online survey and recruited 416 study subjects using
social media as the main method of recruitment. We gathered demographic information, GI …

Recently, tolerance interval approaches to the calculation of a shelf life of a drug product
have been proposed in the literature. These address the belief that shelf life should be related …

The rational design and selection of formulation composition to meet molecule-specific and
product-specific needs are critical for biotherapeutics development to ensure physical and …

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 …

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. …

Low pH inactivation of enveloped viruses has historically been shown to be an effective
viral inactivation step in biopharmaceutical manufacturing. To date, most statistical analyses …

Multivariate conditional regression using a Bayesian estimation approach for the
development of a surrogate dissolution model as part of a comprehensive Process Analytical …

A novel method for the qualification of reduced scale models (RSMs) was illustrated using
data from both a 250‐ml advanced microscale bioreactor (ambr) and a 5‐L bioreactor RSM for …

With the rapid adoption of continuous manufacturing (CM) in development and manufacturing
operations, it is commonly acknowledged that end-to-end data integration is critical for …

This thesis considers two related problems that has application in the field of experimental
design for clinical trials: