Fundamentals of Dissolution: Guidance for the Verification and Qualification of a Dissolution Apparatus
교육등록 : 아래 사이트 또는 담당자 이메일(shin.kim@usp.org)
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General Public |
Day 1: March 16, 2021
• Introduction: USP, Standards Development Process, Dissolution Resources
• Dissolution Theory and Historical Highlights
• Compendial Dissolution Testing
o Dissolution Testing in drug product monographs
o USP General Chapter Requirements o Harmonization of USP
o Four main dissolution apparatus used for dissolution testing
Day 2: March 17, 2021
• Qualification of Dissolution Apparatus
o Identifying and controlling sources of variability in dissolution test results
o Mechanical Qualification of dissolution apparatus
o Performance Verification Test (PVT)
Day 3: March 18, 2021
• Data Handling and Acceptance Tables
• Examples and feedback regarding PVT
• Open Question & Answer Session