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SUMMARY:Advancing Bioequivalence Frameworks for Inhalation Drug Products
DESCRIPTION:The Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro\, In Vivo\, and In Silico Methods workshop\, co-hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG)\, will take place on October 14–15\, 2026\, in Rockville\, Maryland\, with both in-person and virtual attendance available. \nThe two-day workshop will bring together experts from FDA\, academia\, industry\, and other stakeholders to discuss current regulatory expectations\, scientific challenges\, and emerging approaches for demonstrating bioequivalence of complex generic inhalation products\, particularly metered dose inhalers and dry powder inhalers. \nTopics include realistic particle size distribution studies\, dissolution methods\, particle morphology testing\, in vivo pharmacokinetic studies\, potential alternatives to charcoal-block studies\, strength waivers\, in silico approaches\, and strategies for products with significant formulation differences from their reference standards.
URL:https://oncodaily.com/event/advancing-bioequivalence-frameworks-570579
LOCATION:The Universities at Shady Grove (USG)\, Building II\, Ballroom\, 9630 Gudelsky Drive\, Rockville\, MD\, 20850\, United States
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