OCULAR DRUG DELIVERY ARTICLES
Use-Related Risk Analysis: Considering The FDA Guidance On URRA
The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential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.
OCULAR DRUG DELIVERY VIDEOS
In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC, and Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie, use a hypothetical case study for an on-body injector (OBI) to demonstrate a template for identifying EDDOs.
In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC uses a hypothetical case study for a meter dose inhaler (MDI) to demonstrate a template for identifying EDDOs.
In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC, and Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie, use a hypothetical case study for a prefilled syringe (PFS) to demonstrate a template for identifying EDDOs.
What constitutes an EDDO (Essential Drug Delivery Output)? In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC illustrates how to identify system-level drug delivery outputs that are device-dependent and, therefore, essential.
OCULAR DRUG DELIVERY RESOURCES
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![GettyImages-525062561-syringe-vaccine-injection-subcutaneous]( "Rational Design And Development Of Long-Acting Injectable Dosage Forms")
The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
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![science drug development data iStock-1209661917]( "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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![GettyImages-1398310603-Ophthalmology_Exam_Eye]( "New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology")
Challenges specific to eye physiology complicate the development of new therapies and necessitate innovative drug delivery methods. Biodegradable polymers show promise in addressing these challenges.
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![GettyImages-851771510-eye-futuristic-scanning]( "Ophthalmic Drug Delivery")
Explore the challenges to effective delivery of drugs to the eye, intricacies of ophthalmic drug delivery, and advantages of nanoparticles as an enabling technology for ocular drug-delivery systems.
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![combination]( "Combination Products: Market Trends And Regulatory Considerations")
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
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![Nanoform]( "Small Is Powerful And Sustained")
Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.
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![GettyImages-1206035004-spectroscopy-lab]( "Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway")
Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.
OCULAR DRUG DELIVERY SOLUTIONS
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![Stevanato Group - Aidaptus]( "Aidaptus® Manufacturing")
We are the exclusive manufacturing partner for this innovative auto-injector platform.
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![Scientist Using Tablet In Lab GettyImages-1354172577]( "PBPK Predictive Modeling Services")
Early identification of potential absorption risks is critical for rapid and efficient drug development. Lonza's PBPK modeling services are designed to de-risk your drug development program.
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![Ampoule Aseptic Filling GettyImages-1490244818]( "Your Trusted Partner Of Choice For Pre-Filled Syringe Success")
At Pfizer CentreOne, we are in a unique position to offer you Pfizer’s experience in the development and commercial manufacture of pre-filled syringes.
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![GettyImages-1425605790 Life Sciences Training. Scientists Using A Computer In A Lab]( "Meet The Unique Needs Of Your Sterile Injectable")
Discover how Pfizer CentreOne can meet the unique needs of your sterile injectable with global Pfizer expertise, reliability and flexibility to support your project every step of the way.
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![Vaccine injectable vials and syringe GettyImages-1252804942]( "Unlocking The Potential Of Your Sterile Injectable")
Learn how a CDMO with robust processes and specialized technologies like automated fill lines can help you speed to market while maintaining consistently high quality of your product.
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![GettyImages-1327623919-lab]( "Get Your Biologic To Clinic And Market Faster")
We are your one integrated partner with the expertise to get your therapeutic product to market faster, helping you accelerate, simplify, and de-risk your biologics.
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![Aseptic Filling GettyImages-1087219366]( "Drug Product Fill Finish And Formulation Solutions")
Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.
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![adare]( "A Technology-Driven CDMO Delivering Integrated End-To-End Services")
Explore this interactive PDF with information about technologies & end-to-end integrated CDMO services provided by Adare Pharma Solutions.
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![West]( "What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?")
As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
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![softgel]( "Find The Right Dosage Form To Suit Your Molecule")
Explore the importance of choosing the right partner to develop your Rx softgel drug.
