Inhalation Drug Delivery Videos
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Formulation Technologies For Developing Dry Powders For Inhalation
Examine challenges and key considerations for spray-dried formulations for inhalation, along with a review of current technologies and approved products utilizing particle engineering approaches.
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What Types Of Products Are Assessed With A URRA?
12/11/2024
What types of products in development may need to be assessed in accordance with the FDA’s URRA (Use-Related Risk Analysis) guidance? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, describes several common scenarios that illustrate when a URRA approach may or may not be needed.
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What Happened to CAPA (Corrective and Preventive Actions) Requirements?
7/11/2024
Is CAPA still part of the requirements picture for the new QMSR? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses changes in the treatment of corrective and preventive actions.
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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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Developing Regulatory Strategies For Combination Products
12/16/2024
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor Susan Neadle. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.
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The Role Of Terminology In Regulating 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 panelist Barr Weiner to describe the role of case study examples in defining and regulating combination products globally. Weiner makes the case for agreement about the science and technology being more important than commonality in terminology, Panelist Fran DeGrazio agrees.
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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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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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Setting The Strategic Direction For Advanced Therapy Products
10/8/2025
In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, underscores the importance of cascading business and regulatory strategies for advanced therapies and delivery products throughout the organization’s quality management systems.
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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.