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The FDA draft guidance on Use-Related Risk Analysis (URRA) announced in July 2024 helpfully clarified key considerations regarding the identification and mitigation of potential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 unique episode of In Combination, series host Tom von Gunden, Chief Editor at Drug Delivery Leader, puts himself in combination with DDL Executive Editor Fran DeGrazio as the two share perspectives on drug delivery trends.
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 7 on human factors engineering (HFE) from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the chapter’s co-authors.
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 6 on risk management from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Edwin Bills.
The discussion highlights key aspects of a biopharma organization’s business and operations that must be effectively integrated when developing drugs and devices in tandem. These include imperatives such as establishing common terminology, applying QbD (Quaility by Design) principles, and managing supplier controls for providers of constituent parts.
OCULAR DRUG DELIVERY RESOURCES
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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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![gettyimages-471932801-170667a]( "Pharmaceutical Nanotechnology: What To Know")
Here is what you need to know about the key advantages that pharmaceutical nanotechnology provides in improving drug efficacy and decreasing adverse reactions.
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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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![gettyimages-1305313838-170667a]( "Ophthalmic Formulation Development: Inside Ophthalmic Preparation")
Understand why the demand for CDMOs with experience in the formulation of ophthalmic products is on the rise.
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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-1044232264-team-lab-collaboration-teamwork-planning]( "Four Challenges That Stall Advanced Therapy Development")
Many challenges can stall an advanced therapy’s development. The vast majority of them are tied to inadequate preclinical planning and partner vetting.
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![iStock-827581062-lab-computer]( "An Elegant Solution For Delivery Of Acid Sensitive Pharmaceuticals")
Sustained release drug delivery products offer effective therapies in the treatment of serious chronic diseases, and their development requires customized solutions with tunable material properties.
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.
