Infusion Drug Delivery Articles

  1. A Critical Analysis Of FDA Human Factors IFU Guidance For Drug Delivery Devices 5/8/2024

    Drug administration by lay users is becoming more common. Is current FDA guidance viable for demonstrating safe and effective use for critical devices and systems? No.

  2. 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.

  3. Midline Catheters Show Fastest Growth Rate In Vascular Access: A Global Market Analysis 12/12/2023

    In many situations, midline catheters present a superior choice compared to short peripheral catheters, which are suitable for brief indwelling periods, and PICCs, which carry a higher risk of central line-associated bloodstream infection (CLABSI) and are more complex to insert. Let's examine new market research.

  4. 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.

  5. 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.

  6. 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.

  7. Emerging Trends In Infusion/IV Therapy 9/20/2023

    The infusion therapy market in the U.S. is growing rapidly, driven by an aging population and the increasing prevalence of chronic diseases. This article shares new market research, with a look at macro trends as well as trends in infusion pumps, IV sets, needleless connectors, stopcocks, IV filters, and blood transfusion sets.

  8. Global Market Trends For Drug–Device Combination Products 9/12/2023

    Drug–device combination products, also known simply as combination products, have a wide range of applications, including drug-eluting stents, prefilled syringes with medications, inhalers with drugs, transdermal patches with therapeutic agents, and more. This article shares new market research.

  9. The Global Market For Generic Sterile Injectables To Double In Value By 2032 5/15/2023

    According to new analysis at insightSLICE, the global generic sterile injectable market size was estimated to be $79.95 billion in 2022 and is expected to grow to reach $159 billion by 2032. What are the key factors and trends driving this growth? This author shares the key data-led insights.

  10. Addressing 3 Challenges Of Developing Or Using A New Excipient 5/8/2023

    As the world discovers new molecular entities, new solutions for and innovation of excipients are more critical than ever. However, they are often overlooked. Let’s look at how to address three key challenges: risk aversion, an inconsistent feedback loop between pharma companies and excipient suppliers, and the current lack of regulatory body-backed innovation programs.