FIP Guidelines for Dissolution Testing of Solid Oral Products скачать в хорошем качестве

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. Learning objectives: • 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 Moderator: Jobst Limberg, Head of Unit Scientific Quality in European Procedures, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) - Germany Panellist: Horst-Dieter Friedel, Former Director, Former Bayer AG - Germany