For combination product regulatory submissions, there is no one-size-fits-all approach. Regulatory pathways and application types vary across global health authorities.
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ON-DEMAND WEBINARS
Learn more about defining the spray drying process with an emphasis on specific enhancements to accommodate scale-up to commercial scale equipment of challenging applications or molecules.
Using a comprehensive approach to component selection mitigates risks to fill-finish and lyo processing. Explore key considerations for selecting lyophilization stoppers suitable for intended use.
Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.
‘Brick dust’ compounds require additional steps if spray drying is to yield a commercially attractive process. Explore three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
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Autoinjectors: A Revolutionary Leap In Drug DeliveryExplore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.
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Pediatric Dosage Form Development: Program Design And Formulation DevelopmentExplore key considerations to successfully bridge from initial concept of pediatric program design and formulation development strategies into later stages of development and through to commercialization.
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The Challenges And Opportunities Of Real-World EvidenceThe FDA's Real-World Evidence framework addresses challenges in using Real-World Data for regulatory decisions, emphasizing data reliability, bias management, and successful case studies.
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FAQs On The Revised EU GMP Annex 1: Volume 7Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.
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Delivering The Promise Of Gene TherapyGene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.
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Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) PathwayReview 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.
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New Polymer Overcomes Limits In Sustained Drug Delivery In OphthalmologyChallenges 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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Expanding Opportunities For Inhaled Drug DeliveryReview the challenges and intricacies of effectively delivering drugs to the lung and the advantages of using nanoparticles and gentle particle processing techniques to enable delivery of sensitive drugs.
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Capsule Formulation Development: From Dosage Forms To FillingCapsules are tasteless and easy to take, offer streamlined development timelines, and simplicity of manufacturing. Discover capsule formulation development and the benefits of capsule dosage forms.
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Stability Chambers: Testing, Equipment, And UsesPerforming stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.
TOM'S TAKES ON DRUG DELIVERY
TALKING WITH TOM VIDEOCASTS
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DELIVERED BY DEGRAZIO
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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.
