Inhalation Drug Delivery Videos
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Combination Products Regulatory Considerations with FDA's Barr Weiner
10/1/2024
From his roles and experiences in the combination products and combined use systems arena, John “Barr” Weiner offers perspectives on how to approach pre- and post-market activities with regulatory requirements and guidance in mind. Cross-functional coordination, integrated development, and primary mode of action (PMOA) designations are among the considerations Barr reminds organizations to implement thoughtfully as they work to advance combination products within a regulatory landscape.
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Becoming A Combination Product Development Organization
1/12/2026
In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks the panel to comment on regulatory challenges and considerations for traditional drug product pharma companies moving into combination product development. Patient centricity, device expertise, and supplier relationships are among the topics identified.
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Simultaneous Spray Drying: Dry Powder Inhaler Combination Formulations
The simultaneous spray drying of multiple ingredients is a powerful technique for making inhaled products with multiple actives. Examine how novel techniques can make these products a reality.
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From Powder To Particles With Jet Milling
Gain valuable insights into the jet milling process and Quality by Design approach for inhalation drug delivery and their potential applications in drug development.
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PBPK Modeling: Mitigating Absorption Risks In Early Drug Development
Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.
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Leveraging Combination Therapies For Precision Targeting
10/8/2025
In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, highlights the promise of using combination products and combination therapies to reach difficult targets with precision. Carolyn notes crossing the blood-brain barrier as an example of a key therapy delivery advance.
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An EDDO Identification Tutorial For A Prefilled Syringe (PFS)
4/23/2025
In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC, and Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie, use a hypothetical case study for a prefilled syringe (PFS) to demonstrate a template for identifying EDDOs.
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The Steps In Identifying An EDDO
4/23/2025
What constitutes an EDDO (Essential Drug Delivery Output)? In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC illustrates how to identify system-level drug delivery outputs that are device-dependent and, therefore, essential.
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Managing Risk When Developing Combination Products
2/20/2025
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 6 on risk management from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Edwin Bills.
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Post-Market Surveillance And Post-Approval Changes For Combination Products
1/12/2026
In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks the panel to comment on post-market regulatory considerations and processes for combination products. Among the topics covered are post-approval changes, design outputs, patient safety, and various regulatory guidances.