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RDD Europe 2013 Workshop: Automated Ingredient Specific Particle Sizing

[fa icon="calendar"] Jun 12, 2013 9:00:42 AM / by Admin

RDD_Workshop1Gateway 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.

Download Workshop:

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.

Topics: bioequivalence, Blog, cGMP, Ingredient-Specific Particle Sizing, ISPS, particle characterization, particle sizing, Pharmaceutical

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