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Understand the best practice approaches for designing extraction studies

Extraction studies of pharmaceutical packaging systems, components and materials of construction can be accomplished for a variety of purposes. The design and parameters of an individual extraction study should reflect the unique purpose of that study. In addition, knowledge of the dosage form contained in the packaging system, the chemical composition of the packaging system and its individual components, along with experience based best practices should be considered.

Dr Daniel Norwood notes that the information available from an extraction study should also be analysed based on the overall purpose of the study and with all appropriate due diligence. Hear more guidance from Dan on the intellectual process of designing an extraction study based on knowledge of the packaging system, the purpose of the extraction study, and experience based best practices on Thursday May 8 at Extractables and Leachables USA conference.

There are also further considerations for deciding the correct approach towards E&L testing and Tamara Fridman, CEO of Vanasyl will help identify how sharing knowledge between suppliers and end users can aid this decision. Her discussion will play an essential role in attempting to solve the many conundrums regarding this topic and will hopefully lead to more published content that directly aids this industry, leading to safer drugs and a healthier society.

Historically the practice of designing screening studies for extractables from pharmaceutical packaging materials, drug product delivery systems and components used in manufacturing have been based upon published procedures specific for the given application. An alternative in designing these studies is to base the investigation on the chemical properties of known extractables and then applying statistical distribution models to the collected data. Dr Jim Castner will present a chemometric approach that can provide a more systematic strategy in conducting these investigations across multiple applications, which can then lead to improved risk assessments for extractables from multiple contact surface vectors.

Join in a discussion on the best approaches for designing extraction studies in this expert session at E&L USA.