ENBIS-24 Leuven Conference

Session

Statistics in the pharmaceutical industry

18 Sept 2024, 10:05

Leuven, Belgium

Conveners

Statistics in the pharmaceutical industry

• Marina Vives-Mestres (Curelator Inc.)

44. A Comparative Analysis of Bayesian Sampling Methodologies for Design Space Identification in Quality by Design (QbD) Approach

Deniz Akinc Abdulhayoglu (Cencora Pharmalex)

18/09/2024, 10:05

Biostatistics/ Statistics in the Pharmaceutical Industry

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...

46. A Bayesian approach to accelerated stability modeling and shelf-life determination

Dr Joris Chau (Open Analytics)

18/09/2024, 10:25

Biostatistics/ Statistics in the Pharmaceutical Industry

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...

3. Bayesian non-linear mixed effects model for safer powder storage

Arno Strouwen

18/09/2024, 10:45

Biostatistics/ Statistics in the Pharmaceutical Industry

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...