05th December 2023 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions |BOOK FREE SEAT FOR THIS WEBINAR
It is a well-known adage that “the devil is in the details.” As authoritative texts and regulatory guidelines that address the chemical characterization of medical devices usually present concepts and generalities and lack granularity, sponsors seeking to design and implement extraction studies for medical devices occasionally struggle to establish and justify critical experimental details that are scientifically sound, practical, achievable, and regulatorily compliant.
This presentation provides insights into several of these critical experimental details, addressing concepts that include:
- The “It all comes out at Once” Paradox
- Exhaustive Extractions as a Source of Kinetic Release Data
- Predicting Exhaustive Extractions with a Minimum Number of Extraction Steps
- A Rational (?) Approach to Quantitation and Managing the AET
- Accurate versus Protective Quantitation
- What exactly is a “Semi-polar” Solvent?
Presented by Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions
Dr. Dennis Jenke is the Chief Executive Scientist at Triad Scientific Solutions LLC, a consulting organization that provides integrated, science-based, and practical E&L solutions to the pharmaceutical, cosmetic, food industries. Dr. Jenke retired as a Distinguished Scientist from Baxter Healthcare Corporation where, for nearly 35 years, he was responsible for developing and defending E&L tactics and strategies. He is widely published on E&L and related topics and is an active member of national and international standard setting organizations.
Sponsored by Nelson Labs