Pharmaceutical Dissolution Testing
- In-person Course Delivery – Live Training Sessions
- Attendance for 2 Days Training
- Guided Learning Hours – 16
- Case Studies, Exercises, Q & A,
- Pre-Course Access: Pre-Event Questionnaire, Presentation Slide Deck
Course Overview
Pharmaceutical dissolution test results are influenced by a large number of physical and chemical parameters. Regulators expect that dissolution tests will be robust, adequately precise and, for poorly-soluble drugs, discriminating. This two-day in- person course is aimed at those developing or performing dissolution tests for solid oral dosage forms. It would also be useful for regulatory professionals who would like to understand more about reviewers’ expectations. The 16 hrs face to face course incorporates relevant guidance from the recent ICH Q14 (Analytical Procedure Development) and the updated ICH Q2 (Validation of Analytical Procedures).
Trainer’s Profile
Our Expert Trainer is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. He is an expert in sampling and sample preparation, chromatography (liquid and gas), spectroscopy (atomic and molecular) and pharmaceutical dissolution testing. He was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.
Key Takeaways
By attending this course, delegates will:
- Understand the theory behind drug dissolution
- Appreciate the potential and limitations of in vitro dissolution as a predictor of in vivo performance, including the uses of biorelevant dissolution media
- Learn when a dissolution test should be discriminating and how to demonstrate
discriminating ability - Be able to troubleshoot anomalous dissolution test results in a logical, scientifically sound manner and appreciate the importance of equipment qualification
- Understand how to approach dissolution method development and validation/li>
Who Should Attend
- Analytical development scientist
- Analytical development managers
- Quality control scientists
- Quality control managers
- Quality assurance professionals
- Formulation development scientists who perform dissolution testing
- Regulatory affairs professionals
- Consultants
For participation details contact
Mithun Siddartha
+1 780 851 7197 (Canada)