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FIP Guidelines for Dissolution Testing of Solid Oral Products
Dissolution testing is an important physiochemical test for the development of solid oral dosage forms. As a quality control test, the dissolution test is used for assessment of drug product quality and is specified for batch release and regulatory stability studies. In vitro dissolution test results
can often be correlated with the biopharmaceutical behavior of a product. This webinar provides a summary
of views from major global agencies (Europe, Japan, United States), pharmacopoeias, academia, and
industry. Based on available guidance and literature, this webinar summarizes highlights for development
and validation of a suitable dissolution method, setting appropriate specification.
Clarify the importance of dissolution testing within the pharmaceutical lifecycle.
• Understand the concept of Dissolution Testing
• Learn which parameters are relevant for the development of a dissolution method
• Learn how to validate the dissolution method
• Learn how to set suitable specifications
Jobst Limberg, Head of Unit Scientific Quality in European Procedures, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) - Germany
Horst-Dieter Friedel, Former Director, Former Bayer AG - Germany