Inhalation Drug Delivery Videos

  1. Mitigating The Risk Of Pitfalls In Nasal Drug Product Development

    Intranasal drug delivery offers a promising route for administering medications, but advancing to market can be a difficult journey. Learn about common development pitfalls and how to mitigate risk.

  2. Managing Combination Products Post-Market 3/25/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 8 on post-market lifecycle 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 Khaudeja Bano.

  3. Drug Delivery Market Success: Lessons From A Discontinued Product 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, host Fran DeGrazio and James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, ponder the discontinuation of Repatha® Pushtronex®. They comment on how its withdrawal may illustrate key market drivers and factors that bolster a product’s success or, alternatively, lead to its demise.

  4. Partnership And Clinical Trial Strategies For Digitally Connected Devices 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, and Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, discuss key product development considerations when bringing digital connectivity solutions to drug delivery devices. These aspects include product and health authority partnerships, clinical studies, and regulatory approvals.

  5. What Is the Impact of the New QMSR on 21 CFR Part 4? 7/11/2024

    In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio enlists consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to summarize where Part 4 is documented in the new guidance.

  6. Clarifying The EDDO Focus On Design Outputs, Not Design Inputs 10/9/2024

    In what ways are Essential Drug Delivery Outputs (EDDOs) different from design inputs for combination products? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC explains the difference.

  7. Rapid Development Of Amorphous Solid Dispersions For Bioavailability

    See how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro studies and in silico modeling. Understand how ASD formulations can enhance bioavailability.

  8. Dry Powder Inhaler Services

    We offer comprehensive solutions for Dry Powder Inhalers (DPIs), encompassing all stages from initial formulation screening to clinical-scale manufacturing.

  9. An EDDO Identification Tutorial For An On-Body Injector (OBI) 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 an on-body injector (OBI) to demonstrate a template for identifying EDDOs.

  10. Preconditioning Devices under EDDO Guidance 10/9/2024

    What does the FDA’s guidance on Essential Drug Delivery Outputs (EDDOs) mean for activities involved in preconditioning the device delivery components of combination products? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, discusses the likely intent and impact of EDDOs on preconditioning for both manufacturers and sponsor companies.