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“Real-time release for dissolution testing of an oral solid dosage form – case study from industry (part I) and regulatory expectations (part II)”
In this webinar a speaker from the B Federal Institute for Drugs and Medical Devices
and from AstraZeneca each will discuss aspects of ICH Q13 related to continuous manufacturing and real time release testing with a special focus on dissolution testing. Specifically, Dr. Dumarey will start the webinar by presenting a case study of how to approach real-time release testing for an oral solid dose formulation. In the second half of the webinar, Dr. Limberg will discuss the assessment of prediction models for quality attributes”.
- Andreas Abend, Senior Principal Scientist MSD - USA
- Melanie Dumarey, Associate Director at AstraZeneca - Sweden
- Jobst Limberg, Head of Section Scientific Quality in European Procedures, Federal Institute for Drugs and Medical Devices - Germany