Introduction to Dissolution Method Development & Validation 2016

Topics

• Strategies for selecting dissolution conditions, including medium, apparatus and time points
• Several different reasons for developing dissolution methods, and corresponding differences in the approaches
• Trending of results and change control
• Why dissolution method validation is more complex than that for other methods
• Pointers for proposing specifications

Who should Attend

Attendees from:

• Formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution
• Chemists (Research, Quality Control, and CRO; Human, Veterinary or Generic) involved with dissolution method development or testing and their managers