Inhalation Drug Delivery Videos
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Why Start A URRA Early In Combination Product Design?
12/11/2024
Both a URRA (Use-Related Risk Analysis) and IFU (Instructions for Use) can help to mitigate the risk of user misuse of a combination product. In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers rationale for starting and conducting the URRA ahead of developing or finalizing IFU.
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Dry Powder Inhaler Services
We offer comprehensive solutions for Dry Powder Inhalers (DPIs), encompassing all stages from initial formulation screening to clinical-scale manufacturing.
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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.
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Understanding How EDDOs Relate To CGMPs
4/23/2025
How are EDDOs (Essential Drug Delivery Outputs) related to CGMPs (Current Good Manufacturing Practices) during the design of a drug-led or biologic-led combination product? 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 establishes the connection between the two regulatory concepts.
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Drug Delivery Self-Administration: The Rise Of The Epinephrine Autoinjector
5/23/2025
In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Courtney Evans, principal consultant at Suttons Creek, comments on drug delivery technology advancements, particularly around the challenge of greater reliability. Her commentary begins with the market introduction of epinephrine autoinjectors and moves to more recent advances in nasal spray alternatives.
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Particle Size Control Through Micronization: Challenges And Solutions
What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.
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Integrating Development Processes For Combination Products
1/27/2025
The discussion highlights key aspects of a biopharma organization’s business and operations that must be effectively integrated when developing drugs and devices in tandem. These include imperatives such as establishing common terminology, applying QbD (Quaility by Design) principles, and managing supplier controls for providers of constituent parts.
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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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Improve The Performance Of Your Small And Large Molecule Medicines
7/23/2024
Explore the latest in nanotechnology advancements including recent clinical data, formulation applications, and API optimization to NanoImprove formulations.
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What Is There to Learn from a Combination Products Handbook? Plenty!
10/15/2024
In this initial episode of The Combination Products Handbook: The Series, a chapter-by chapter videocast series introducing topics from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023), host Tom von Gunden discusses the book’s intent with its editor, Susan Neadle. The discussion focuses on the rationale for each chapter and the expert contributions of various chapter authors and co-authors.