Transdermal Drug Delivery Videos
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Considering Human Factors In Combination Product Design And Use
3/7/2025
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 7 on human factors engineering (HFE) from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the chapter’s co-authors.
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Patient Adoption Of On-Body Delivery Systems
5/23/2025
In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, panelists Carolyn Dorgan and Courtney Evans from delivery device consultancy Suttons Creek talk with host Fran DeGrazio about factors creating challenges and opportunities in moving patients to on-body injectors (OBIs) and other wearable drug delivery systems.
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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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Relying On Human Factors Clinical Data For Regulatory Approvals
2/17/2026
In this segment of the Drug Delivery Leader Live online event, Injected, Infused, or Implanted: A Penetrating Look At Patient Centricity, Chief Editor Tom von Gunden relays an audience question about increased FDA regulatory scrutiny around human factors. Panelists Jonathan Amaya-Hodes and Shannon Hoste comment on the importance of clinical data in regulatory submissions and in approval pathways.
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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.
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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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Knowing When To Lock Down A Biologics TPP
4/13/2026
In this segment of the Drug Delivery Leader Live online event, Large Molecule Biologics Delivery: Aligning Formulations, Doses, And Devices, Chief Editor Tom von Gunden directs to panelist Rubi Burlage an audience question about timetable for finalizing a TPP (Target Product Profile) during product development. While acknowledging the iterative nature of a TPP, Burlage recommends Phase III as the ideal stage for a lockdown and advises against late changes at validation.
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Selecting Injection Devices And Platforms
2/17/2026
In this segment of the Drug Delivery Leader Live online event, Injected, Infused, or Implanted: A Penetrating Look At Patient Centricity, Chief Editor Tom von Gunden asks panelist Fran DeGrazio to explain how dosing influences delivery device or platform selection. She illustrates key considerations with examples including prefilled syringes and autoinjectors.
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What's In A Combination Product Development Lifecycle?
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, lays out the phases and key activities in the development of a combination product or combination therapy. She underscores the importance of integrated development when merging medicinal product development with delivery device development.
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Preparing Early For Regulatory Marketing Submissions
2/17/2026
In this segment of the Drug Delivery Leader Live online event, Injected, Infused, or Implanted: A Penetrating Look At Patient Centricity, Chief Editor Tom von Gunden asks panelist Jonathan Amaya-Hodges to comment on weaving patient-centric product considerations into regulatory approaches. Amaya-Hodges points to early preparation for marketing submissions as key.