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Orthogonal API Particle Size Methods for Structural Equivalence & In Vitro Bioequivalence

June 25, 2018

Join Gateway Analytical and our partner, Next Breath, An Aptar Pharma Business, for our webinar presentation, Orthogonal API Particle Size Methods for Structural Equivalence and In Vitro Bioequivalence. Topics covered will include analytical techniques and methods suitable for API particle sizing and in vitro bioequivalence for nasal drug products as well as preparation methods and a review of case studies. The presentation will also provide FDA guidance related to particle size distribution (PSD) and regulatory considerations for PSD testing. The goal of the webinar is to educate drug manufactures on analytical testing methods that would enable them to adhere to FDA regulations related to strict control of nasal drug product quality and safety.

Gateway Analytical and Next Breath are equipped with state of the art instrumentation and knowledge of up to date regulatory requirements to offer streamlined analytical guidance for drug manufacturers.

Dave Exline
President; Gateway Analytical

Julie D. Suman
Co-Founder & President; Next Breath, An Aptar Pharma Business

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