In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.
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- Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet
- Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms
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ON-DEMAND WEBINARS
A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the mAb impacts the overall behavior of the drug product.
Review the advancing mass spectrometry, biophysical characterization, automated sample preparation, and high throughput analytics required to deliver medicines in a safe, compliant, and efficient manner.
Review a commercially-ready process capable of reproducing spray-dried dispersions with less manufacturing complexity and environmental impact, and out-designing and outperforming spray drying.
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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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.
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![GettyImages-1370115311 outsourcing]( "Contract Design And Development Vs. In-House: Finding The Best Fit")
Contract Design And Development Vs. In-House: Finding The Best FitOutsourcing medical device R&D to Contract Development Organizations (CDOs) aids innovation, scales resources, and overcomes constraints. Strategic evaluation ensures successful partnerships.
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![magnifying glass w pills 450x300]( "Analyzing Product Formulation Using Raman Microscopy")
Analyzing Product Formulation Using Raman MicroscopyRaman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.
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![GettyImages-597971944-viral-vector-AAV-adeno-associated-virus]( "Critical Steps To Optimize Viral Vector Manufacturing With CDMOs")
Critical Steps To Optimize Viral Vector Manufacturing With CDMOsTo develop a fruitful viral vector manufacturing process and a mutually beneficial relationship between sponsor and CDMO, learn to balance cost, quality, and timeline via transparent communication.
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![GettyImages-1435081495-Self-Injector_Auto-Injector]( "Autoinjectors: A Revolutionary Leap In Drug Delivery")
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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![BD Medical-1]( "Gliding Towards De-Risked Combination Product Development")
Gliding Towards De-Risked Combination Product DevelopmentLearn about the critical role plunger stoppers play in determining a combination drug product's exposure to extractables and leachables.
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![131]( "Gamification: The Answer To Pharma's Non-Adherence Crisis?")
Gamification: The Answer To Pharma's Non-Adherence Crisis?Digital connectivity is transforming the consumer experience and digital technology can now improve the patient experience too, in ways that were just not possible before.
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![West1]( "Evaluation And Identification Of Subvisible Particulate Matter In Injections")
Evaluation And Identification Of Subvisible Particulate Matter In InjectionsReview the scopes of USP chapters <787> and <788>. Both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.
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![GettyImages-597935610 cell and gene]( "A Continuous Electroporation System For Viral Gene Therapy")
A Continuous Electroporation System For Viral Gene TherapyExplore the development work involved for the individual technologies that make up an innovative and scalable, chemical-free continuous viral vector production platform.
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![GettyImages-950086574-oral-solid-OSD-pill-tablet-capsule-development]( "Strategies For Accelerating The Development Of Modified Release Oral Forms")
Strategies For Accelerating The Development Of Modified Release Oral FormsCareful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.
Tom hosts multiple videocast series providing expert takes and insider perspectives on drug delivery:
In her monthly column, Fran offers keen industry insights exclusively on Drug Delivery Leader.
FRANKLY FRAN
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![frankly-fran-better]( "Drug Delivery Innovation: If You Build It, Will Anyone Care?")
In this article, Fran DeGrazio explains why innovation in drug delivery technologies may not need to be revolutionary, but will no doubt need patient adoption, payor support, and regulatory follow-on to become sticky in the marketplace.
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.
