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 on the opportunity for analytical procedure developments to follow a similar approach. Authorities such as US Pharmacopoeia and ICH are currently preparing tomorrows regulations to implement Analytical QbD and introducing the idea of Analytical or Assay life cycle such as ICHQ14 and USP 1210 documents. The life cycle steps of a bioassay, that are development, optimization, validation, transfer, comparisons and bridging are all interconnected and should ensure the results produced remains of acceptable quality. Indeed, analytical methods and bioassay results are used to make crucial decisions about the development of the drug products to assess their efficacy and safety.
This webinars aims at showing the different steps to smartly use all information gathered throughout the life-cycle of the analytical method and bioassay to ensure its fitness of purpose. Combining scientific knowledge with adequate statistical methodologies has a crucial role to play: such as design of experiments, statistical modeling, design space definitions and probabilistic statements. Accumulating the knowledge of the analytical method or bioassay performances gathered at each step ensures the release of useful measurement systems, that are under control and that allows making the right decisions with confidence.
Director Statistics, PharmaLex
Eric Rozet is Director Statistics at PharmaLex Belgium company in Louvain-la-Neuve (Belgium). He has an experience of more than 15 years in pre-clinical, non-clinical statistics and CMC in particular in statistical aspects related to (bio)assays and (bio)processes development, optimization, validation, transfers. He trains statisticians and analysts of the Bio-Pharmaceutical Industry on topics such as optimization, validation, robustness and transfer of analytical methods and processes. Eric also trains Statistician into Bayesian modeling and Designs of Experiments. He is also author of more than 100 articles and book chapters in applied statistics and is regularly giving conferences on these subjects. Eric has a B.Sc. degree in Bio-engineering, a Master degree in Biostatistics and a PhD degree in Pharmaceutical Sciences.
Director Statistics, PharmaLex
Pierre Lebrun is Director Statistics at Pharmalex Belgium, 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. Two years ago, 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.
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