Featured Editorial
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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.
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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.
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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.
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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.
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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.
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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.
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The Most Difficult Outsourcing Tasks
9/6/2023
Hint: According to long-termed Pfizer supply-chain professional Francis Dumont, it is sterile-fill. Learn about that and much more on working effectively with CDMOs to optimize production.
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Respiratory Viral Infections: The Next Frontier For Antiviral Drug Development
8/29/2023
There is still no approved antiviral therapy for adults with RSV infections. As drug developers, we need to prioritize developing new antiviral therapies for immunocompromised patients.
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4 Tips To Leverage Your Ingredient Supplier For Faster Formulation
8/3/2023
Speed to formulation plays a critical role in recouping the investment for a new drug. Many ingredient suppliers have an experienced analytical group and material scientist group, and drug developers should reach out and leverage that expertise with these four strategies.
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Embracing AI-Driven Technology In Drug Development, Manufacturing
7/14/2023
Pharmaceutical technical development and manufacturing can benefit from using large language model (LLM) generative AI systems. Specifically, in the areas of drug-device combination products, cell and gene therapy products, and in continuous manufacturing technology, AI can emerge as a key catalyst for advancements in patient safety and product reliability.