Basic and advanced Stability analysis
- Why study stability?
- An introduction to kinetics, The effects of temperature
- Basic statistical principles, Regression analysis
- Guidance documents, Multiple lots, Performing an ICH analysis
- Fundamentals of specifications
- Clinical support of specifications
- Release models
- Accelerated and stressed studies
- Comparison after process change
- Ongoing stability studies
- Maintaining specifications post-licensure, Evaluating Product after a Temperature Excursion, OOS, OOT
- Release limits.
Laurent Natalis is a non-clinical statistician consultant working as Associate Director Statistics at PharmaLex (Belgium). After a PhD in Evolutionary Ecology at the Earth and Life Institute (UCL, Belgium), Laurent joined the pharmaceutical world in 2010 in a biotech focused on the development of cell therapy. In 2013, he joined PharmaLex and contributed to the implementation of Bayesian statistics in various non-clinical fields, including stability studies, specification settings, DoEs, Design Space definition, Internal Release Limits computation, gage R&R studies, and application of QbD paradigms to the pharmaceutical industry. Laurent has a strong expertise in the application of Bayesian methodologies to mimic and optimize various CMC processes.
Pierre Lebrun is Director Statistics at Pharmalex, which Belgium arm is dedicated to statistical expertise. During more than 14 years, Pierre specialized in quality-by-design aspects related to processes and assays, with a strong emphasis on the use of Bayesian statistics to improve knowledge during the process and assay validation stages. Pierre is also a recognized trainer in statistics for the pharmaceutical industry, including design of experiments, Bayesian statistics, statistical process control, and assay development and validation.
Pierre joined the USP panel in charge of the development of the USP 1220 chapter about a holistic approach to assay validation using the concept of the analytical procedure lifecycle. He also gives lecture on DoE at Liège university (Uliège, Belgium) and collaborates with the research team on new chemometrics and statistics methods for analytical development, validation and PAT. Pierre’s work in applied statistics can be found in 150+ international peer-reviewed papers, book chapters and conference proceedings on these subjects. Pierre Lebrun holds a master’s degree in computer sciences and economy, followed by a master in statistics at the university of Louvain-la-Neuve in Belgium. He completed his PhD in statistics from University of Liège.