Home infusion can lower costs and improve access, but requires complex coordination, patient readiness, logistics, and monitoring to ensure safe and effective care.
- Need A Drug Delivery Conversation Starter? Try Target Product Profile
- When Software Becomes Part Of The Medicine
- Prevascularized Bio-hybrid Organ Platforms Are Redefining Cell Therapy Delivery
- Treatment Adherence And Designing Therapeutics To Meet Patient Needs
- Complaints Into Practical Action: Human Factors Drug Delivery
- Human Factors: A Key Factor In Regulatory Approvals
- Regulatory Attention To Human Factors: How Much Is There?
- Gaining An Edge In GLP-1 Production
ON-DEMAND WEBINARS
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Learn how evolving ophthalmic regulations, contamination control strategies, and advanced packaging solutions can help support compliance, product quality, and patient safety.
Explore the science behind LNP formulation development, from ionizable lipids to scalable manufacturing through case studies, screening strategies, and flexible approaches for advancing next-generation therapeutics.
Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost efficiency, supply chain continuity, and patient benefit.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![istock1087218874-lab-drug]( "Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages")
Lyophilization vs. Liquid Formation: Why Lyo Offers AdvantagesLyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.
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![GettyImages-1353123922-doctor-patient]( "Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls")
Why 'Off-The-Shelf' Devices Do Not Circumvent Design ControlsUtilizing off-the-shelf (OTS) devices for drug delivery can offer significant advantages to development programs in timeline and risk mitigation. Understand the design control responsibilities of a sponsor when using OTS devices.
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![WEST-Labs 168_ViewingQuarter-0052]( "Safely Navigating The Transition From MDD To MDR")
Safely Navigating The Transition From MDD To MDRIf devices are integral to positive patient outcomes, device partners must play an integral role to ensure regulatory compliance is achieved in the most effective way.
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![Stevanato]( "Overcoming A Failed Design Verification Test For Your Delivery Device")
Overcoming A Failed Design Verification Test For Your Delivery DeviceIf a drug delivery device fails a design verification test, the consequences can be lost revenue for the pharma company and delays for patients. Explore how to eliminate design verification failure.
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![iStock-1205850790-oral-solid-dose-OSD-tablet-capsule-pill]( "Understanding Of Amorphous Solid Dispersions & Their Downstream Development")
Understanding Of Amorphous Solid Dispersions & Their Downstream DevelopmentUnderstanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs.
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![AST- Fill-Finish Automation And Robotics]( "Small-Scale Aseptic Filling Technology Considerations")
Small-Scale Aseptic Filling Technology ConsiderationsSmall-scale aseptic filling presents a unique set of challenges. Learn what to look for when evaluating small-scale aseptic filling technology.
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![Medical scientists analyzing research-GettyImages-1413600685]( "Integrated Strategies for Achieving Regulatory Milestones Faster")
Integrated Strategies for Achieving Regulatory Milestones FasterLearn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.
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![GettyImages-1279969622-self-injector-injection]( "Streamlining The Path To Market For Generic Drug-Device Combinations")
Streamlining The Path To Market For Generic Drug-Device CombinationsDeveloping g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.
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![iStock-1256322438-lab-research-scientist]( "Nanosuspension Dosage Forms: Product Development & Scale Up")
Nanosuspension Dosage Forms: Product Development & Scale UpFor drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.
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![GettyImages-488719432-bilayer-tablet-OSD-oral-solid]( "Customized Release Through Dispersed Dosage Formats")
Customized Release Through Dispersed Dosage FormatsTypically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.
DELIVERED BY DEGRAZIO
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![Delivered _by _DeGrazio_Logo_Color_2]( "6 Packaging And Delivery Challenges For Biologic Therapies")
6 Packaging And Delivery Challenges For Biologic TherapiesIn this article, Fran DeGrazio identifies six aspects of biologics-based therapy packaging and delivery that, if addressed, may help to ensure successful product development and lifecycle management. They include 1) chemical compatibility with device functionality, 2) long-acting formulations, 3) product stability, 4) primary packaging and device integration, 5) cold storage, and 6) higher concentrations and viscosities.
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
