One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain.
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ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Successful Industrialization Requires Solid Foundations
Learn how choosing the appropriate quality of containment systems from the outset is critical to the successful industrialisation of an injectable drug product and review some of the associated challenges.
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Development Of Next Gen Sustained Release Solutions For Pain Management
A TheraPEA™ polymer based injectable formulation designed to deliver the same dose of Triamcinolone Acetonide (TAA) as in Zilretta® has shown promising results in a series of pre-clinical studies.
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Nanoformed API: A Superior Alternative To Solid Dispersions
Cutting-edge nanotechnology is now emerging, able to address bioavailability challenges and deliver higher drug loads in more patient-friendly formats with fewer and smaller pills and easier regimens.
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An Insoluble Problem? Oral Drug Solubility With Functional Polymers
Review the basics of solubility enhancement and the formulation and manufacture of products that enhance solubility and common questions on the topic.
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A New Framework For Identifying Nitrosamine Risks And Derisking Products
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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Is Your Combination Product Drug-Led Or Device-Led?
The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”
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Improved Bioavailability In 12 Weeks
A lead compound showed clinical promise but had limited bioavailability owing to low solubility. Learn about the challenges, including the molecular characterization and limited budget, and the structured 3-step approach.
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Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products
IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.
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Why It Is Never Too Early To Consider Tungsten Interactions
A key challenge to sensitive biotechnological or biologic drugs, especially proteins, is the potential presence of tungsten and tungsten oxides from the syringe forming process.
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Improve Solubility And Spray Drying Throughput For Brick Dust Compounds
This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.
Tom hosts multiple videocast series providing expert takes and insider perspectives on drug delivery:
FRANKLY FRAN
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The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential hazards in biopharmaceutical product use. In this article, Fran DeGrazio comments on the guidance in a follow-up to a Drug Delivery Live! online event she moderated on the topic of URRA.
- Drug Delivery Outlook: 7 Waves To Ride In 2025 And Beyond
- 5 Top-Of-Mind Drug Delivery Topics In 2024
- Understanding Essential Drug Delivery Outputs: Things To Know About EDDOs
- 5 Keys to Supplier/Purchasing Controls – And Product Quality
- Preparing For The FDA QMSR: Will You Be Ready?
- Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing
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- Embrace Packaging and Delivery Systems Designed for Today's Standards
- The Key to Regulatory Innovation? Global Harmonization