Featured Editorial

51. Understanding Human Behavior To Help Improve Patient Adherence 11/29/2023

    In clinical trials, early dropout rate across all conditions still hovers around 30% and almost 70% of the protocol deviations are potentially linked to non-adherence. The BEAMER project, in part, sets to remedy that.

52. 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.

53. 6 PEG Alternatives You Should Be Thinking About 11/22/2023

    PEGylation is a common way to minimize off-target effects and general toxicity, but it also poses life-threatening risks because it prolongs the drug's time in the bloodstream. Scientists are exploring these alternatives to combat the risk.

54. 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.

55. Biochips: The Small Devices With Big Promise 11/14/2023

    Biochips are small medical devices with microarrays for carrying out biochemical processes. Biosensors enable the screening of different biological materials like enzymes, proteins, DNA, biological molecules, and more, and are used in drug discovery and research. They can also be implanted in the body for targeted drug delivery or to track health data.

56. Enteric Gel Capsules Market Flourishes As Demand For Advanced Drug Delivery Surges 11/7/2023

    Enteric gel capsules ensure medications are released in the small intestine rather than the stomach, enhancing drug efficacy while minimizing gastrointestinal side effects, and making them a preferred choice for patients. This article examines new market research insights.

57. FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance 11/2/2023

    As a response to recent observations regarding the contamination of eye drops, the FDA published draft guidance titled Quality Considerations for Topical Ophthalmic Drug Products on Oct. 13, 2023. In addition to addressing quality considerations, the guidance also provides recommendations about the CMC documentation. The deadline for submitting public comments is Dec. 12, 2023.

58. 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.

59. 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.

60. 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.