Inhalation Drug Delivery Articles

51. Tackling 3 Challenges In Developing An Inhaled Gene Therapy 1/5/2024

    Inhalers hold great potential for delivery of high concentrations of gene therapy directly into the lung. This article shares the experiences of a team who have worked on the development of a gene therapy to treat cystic fibrosis.

52. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3 12/20/2023

    This is the third article in a series of three articles. It continues the discussion of measurement system analysis using continuous gage R&D studies by sharing a generic example using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.

53. Key Regulatory-Fueled Updates On Combination Products As We Enter 2024 12/15/2023

    In late November, AFDO/RAPS held their annual Combination Products Summit in Fort Worth, TX. The meeting is co-sponsored by the FDA with heavy involvement from the Office of Combination Products, and its representatives covered several themes on the subject as we prepare to enter 2024.

54. Human Factors Considerations For Your Emergency Use Drug Delivery Device 11/27/2023

    Emergency use medical devices have seen the autoinjector EpiPen leading the way, followed by the emergence of naloxone nasal sprays and autoinjectors for the treatment of opioid overdose, and others. There are use-related challenges in emergency situations, so you will need to give careful consideration to the human factors involved with who is using the device and how it is accessed.

55. How To Make The FDA Happy: 7 Medtech Design Pro Tips For Combination Products 11/16/2023

    This article shares pro tips related to usability studies, design controls, and other human factors engineering best practices to make the FDA happy with your combination product.

56. FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products 10/31/2023

    Developing an effective combination product can be easily undone if it is not used correctly, and errors made by patients or clinicians are often a direct result of design limitations. To support the co-packaged design process, the FDA has issued a new guidance document titled Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.

57. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2 10/27/2023

    This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.

58. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1 10/6/2023

    All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a 3-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.

59. Emerging Market Trends For Drug Delivery Devices 10/5/2023

    The market for drug delivery devices is growing and it is estimated to reach a market size of $541.5 billion by 2035. This article shares new market research, including segmentation by product type (inhalers, smart pills, drug-eluting stents, and more), routes of administration, regional analysis, and more.

60. Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development 9/14/2023

    The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.