Conveners
Statistics in the pharmaceutical industry
- Marina Vives-Mestres (Curelator Inc.)
Quality by Design (QbD) has emerged as a pivotal framework in the pharmaceutical industry, emphasizing proactive approaches to ensure product quality. Central to QbD is the identification of a robust design space, encompassing the range of input variables and process parameters that guarantee pharmaceutical product quality. In this study, we present a comparative analysis of random walk...
Chemical and physical stability of drug substances and drug products are critical in the development and manufacturing of pharmaceutical products. Classical stability studies, conducted under defined storage conditions of temperature and humidity and in the intended packaging, are resource intensive and are a major contributor to the development timeline of a drug product. To provide support...
Powders are ubiquitous in the chemical industry, from pharmaceutical powders for tablet production to food powders like sugar. In these applications, powders are often stored in silos where the powder builds up stress under its own weight. The Janssen model describes this build up, but this model has unknown parameters that must be estimated from experimental data. This parameter estimation...