PharmaEd’s Extractables, Leachables, & Elemental Impurities, September 15-16, 2014, La Jolla, CA USA
NSF Health Sciences cordially invites you to join us at PharmaEd’s Extractables, Leachables, & Elemental Impurities - West Coast
When: September 15-16, 2014
Where: Sheraton La Jolla, CA
James R. Scull, General Manager, NSF Health Sciences will present on "Extractables & Leachables Considerations for Drug-Filled Implantable Devices"
Setting the Gold Standard in Analytical Testing
- Extractables and Leachables for Medical Devices, Pharmaceutical Packagin; and Single Use/Process Equipment
- Oligonucleotide and Aptamer Analysis
- Clinical and Non-clinical Bioanalysis
- Method Development and Validation
- Stability Testing
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About the Presentation
Drug-Filled implantable devices represent a unique challenge when it comes to evaluating extractables and leachables. As opposed to simple drug-coated implantables, in which both drug and device compounds leach into the body, drug-filled implantables serve as a drug reservoir where the drug elutes through the device rather than off of it. In developing an extractables and leachables testing program for drug-filled implantables, three primary actions must be considered; 1) leaching of device related compounds into the body, 2) leaching of device related compounds into the drug reservoir and 3) leaching of drug-device compound adducts into the body. In addition, leachables from the device into the drug reservoir may negatively impact the safety and/or efficacy of the drug itself.
In general, the study should incorporate components of ISO 10993, PQRI and USP as well as a simulated-use assessment. Considerations for an extractactable and leachable study design, execution and data interpretation will be presented along with a specific case study for an ophthalmic drug-filled implantable device.
About the Presenter
James R. Scull, Ph.D.
General Manager, NSF Heath Sciences
Dr. James Scull has more than 27 years of pharmaceutical development experience spanning all areas from discovery support to Phase III clinical trials. His current responsibilities include providing strategic scientific and technical leadership with a global perspective to NSF’s Health Sciences Division. Dr. Scull is focused on providing clients with technical expertise and project management designed to accelerate the drug development process. Dr. Scull’s primary expertise is in the areas of GLP analytical chemistry, formulation, compliance and separation science. He is also an expert in conducting extractable and leachable studies and oliognulceotide analysis. Dr. Scull holds a Ph.D. in Analytical Chemistry from Villanova University.