Inhalation Drug Delivery Videos

  1. Treating Gastroparesis: From Nose To Stomach With Evoke Pharma's Matt D'Onofrio 12/4/2024

    In this episode of Sit and Deliver, Matt D’Onofrio, CEO of Evoke Pharma, talks with host Tom von Gunden about using nasal delivery to alleviate the discomfort of gastroparesis while smoothing the path for oral drug delivery to patients suffering from it.

  2. Identify And Mitigate Absorption Risks With PBPK Modeling 3/12/2024

    See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

  3. 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.

  4. 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.

  5. Pathways For Pulmonary Delivery

    As orally inhaled drug delivery grows to encompass novel therapies and diverse molecule sizes, CDMOs are rising to meet the demand for specialized knowledge and scalable manufacturing capabilities.

  6. Nasal Spray Development And Manufacturing Services 7/11/2023

    A partner with experts who are adept at working with complex, sensitive, and potent APIs; screening for the optimal formulation; and scaling up efficiently is vital for successful trials and commercialization.

  7. PBPK Modeling: Mitigating Absorption Risks In Early Drug Development

    Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.

  8. The Role of ISO 13485 in the New QMSR 7/11/2024

    What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies explains the relationship between the two guidance documents.

  9. Understanding The Change From EPR To EDDO 10/9/2024

    Why does the FDA’s new guidance on drug-led or biologic-led device design include a change in terminology from Essential Performance Requirements (EPRs) to Essential Drug Delivery Outputs (EDDOs)?  In this segment of the Drug Deliver 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, offers his perspective on how the change in terminology clarifies key concepts related to design controls.

  10. Confirming EDDOs Based on "Device Dependence" 10/9/2024

    Among the characteristics of a device design feature that helps identify it as an Essential Drug Delivery Output (EDDO) is “device dependent.” In this segment of the Drug Deliver 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 differences between the concepts of device-dependent versus device-independent and illustrates why only the former is applicable to an EDDO.