Oral Drug Delivery Videos
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Dramatic Reduction Of Solvent Usage In Pharmaceutical Spray Drying
Using volatile processing aids to increase drug solubility in more environmentally friendly solvents, like methanol, reduces the amount of solvent required to manufacture amorphous solid dispersions (ASDs).
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Rapid, Material-Sparing Feasibility Screening For Hot Melt Extrusion
Discover a screening process to quickly assess HME feasibility that yields more accurate predictions for API loading and degradation while saving material and time compared to traditional approaches.
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A Roadmap For Early Development To Commercial Manufacturing
Learn how to avoid common pitfalls in the transfer and scale-up process using an integrated approach, with industry experts sharing key considerations when planning for scale-up of a development program.
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Advances In Oral GLP-1 Analogs For Obesity
9/12/2024
Discover how these groundbreaking Oral GLP-1 Analogs therapies are reshaping obesity management and addressing key challenges in formulation and delivery.
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Understanding How EDDOs Relate To Design Controls
4/23/2025
How are EDDOs (Essential Drug Delivery Outputs) related to Design Controls during the design and development of a 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 illustrates how the concept of Design Outputs fits within the broader context of Design Controls.
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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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Preparing For Combination Product Regulatory Inspections
4/11/2025
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 9 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, and chapter co-author Kim Trautman.
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Platform Approaches To Personalized Medicines With NanoVation's Dominik Witzigmann
3/20/2025
In this episode of Supplier Horizons, host Tom von Gunden talks with CEO Dominik Witzigmann of LNP (lipid nanoparticle) platform developer NanoVation Therapeutics about addressing a wide range of patient needs while partnering with biopharma and navigating the regulatory landscape to do so.
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The Fusion-Based, Solvent-Free Process Disrupting Spray Drying
3/19/2024
Review a commercially-ready process capable of reproducing spray-dried dispersions with less manufacturing complexity and environmental impact, and out-designing and outperforming spray drying.
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The Regulatory Intent Of A URRA For Combination Products
12/11/2024
To what extent are approaches to conducting risk assessments specified in the FDA 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, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers context-setting perspective on what FDA is looking for when reviewing URRA compliance.