On May 30th, David Exline, Senior V.P. at Gateway Analytical presented a webinar that covered an overview of wear debris characterization for laboratory personnel that evaluate quality issues with medical devices. This webinar focused on the causes of wear debris, the affects of such debris on product quality, acceptable limits and methods for ensuring quality products.
During this recent webinar, Dr. Oksana Olkhovyk presented on the benefits of this novel method of particle sizing that automatically measures particle size distribution. She also discussed specific references to FDA bioequivalence guidance documentation, innovative product design and intellectual property benefits.
This year at Respiratory Drug Delivery 2012, Dr. Oksana Olkhovyk will be presenting a poster with Christopher Vernall from the University of Bath which is located in the UK. This year’s poster topic, titled: “Investigation of the Microstructure of Combination Dry Powder Inhaler Formulations by Atomic Force Microscopy and Raman Chemical Imaging”, aims to investigate the microstructure of commercial Seretide® Accuhaler® using RCI and the cohesive-adhesive balance (CAB) approach to colloid probe AFM.
In 2004, the FDA launched the Critical Path Initiative as a national strategy to drive innovation in development, evaluation and manufacturing of medical products1. As part of this initiative, the FDA identified a number of Critical Path Opportunities (CPOs) for generic drugs. Namely the CPO for Bioequivalence of Nasal Sprays, which identifies a need for direct measurement of particle size equivalence in suspension nasal sprays2.
Last week at PITTCON, Gateway Analytical scientists, Dr. Ryan J. Priore and Dr. Oksana Olkhovyk, presented in the Pharmaceutical - LC, GC and Raman session on the validation of Ingredient-Specific Particle Sizing (ISPS) for nasal suspension products using Raman Chemical Imaging (RCI).