Gateway Analytical Senior Scientist Oksana Olkhovyk, Ph.D. recently presented at RDD Europe 2013 in Berlin, Germany. The workshop titled: “Automated Ingredient Specific Particle Sizing” is now available for download.
This workshop detailed validation methodology for drug PSD based on Raman Chemical Imaging, demonstrating benefits of ISPS as a reliable and effective alternative to in vivo bio-studies for bioequivalence testing over other particle sizing techniques. Several key parameters were reviewed with regard to ISPS cGMP studies applied to a nasal suspension PSD determination, including: determination of representative sampling (population size), accuracy, precision, detection limits, and linearity of the system. Elements of the validation of the ISPS, such as qualitative and semi-quantitative methods for examination of aggregated drug particle size distribution for suspension formulations based on NIST traceable Polystyrene Microsphere Sizing standards, were also discussed from a bioequivalence perspective.
If you have any questions on the presentation, please contact us.