INHALATION DRUG DELIVERY ARTICLES
Risk Is the Spine: What The First 100 QMSR Inspections Reveal
The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
INHALATION DRUG DELIVERY VIDEOS
In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks panelist Barr Weiner to describe the role of case study examples in defining and regulating combination products globally. Weiner makes the case for agreement about the science and technology being more important than commonality in terminology, Panelist Fran DeGrazio agrees.
In what ways are Essential Drug Delivery Outputs (EDDOs) different from design inputs for combination products? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC explains the difference.
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 3 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor Susan Neadle. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.
INHALATION DRUG DELIVERY RESOURCES
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![GettyImages-528041162-lab-testing]( "Simultaneous Spray Drying For Large/Small Mol Combinations")
Gain insights into a “simul-spray” process pioneering for combining small and large molecules into a single, atomized drug product for inhalation administration.
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![Lonza 1]( "Engineering Approaches To Respiratory Drug Delivery")
Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.
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![iStock-474771466-inhaler-inhale]( "Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products")
IVIVR modeling leverages in-vitro testing knowledge toward predicting in-vivo testing results, often reducing long-term development costs by facilitating more informed decision-making during drug development.
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![GettyImages-1426603202-scientist-research-lab]( "Application Of A Novel Temperature Shift Process For Particle Engineering")
Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.
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![GettyImages-1413332879 diabetes]( "10 Ways To Align Your Medical Device With Human Factors Industry Best Practices")
Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.
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![GettyImages-1148337130 product pathway]( "Using 505(B)(2) To Streamline Approval Of Combination Products")
In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.
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![Signing contract-GettyImages-1405364155]( "Contract Design And Development Vs. In-House: How To Find The Best Fit")
Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.
INHALATION DRUG DELIVERY SOLUTIONS
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![GettyImages-1585548490-modular-facility-laboratory-drug-development]( "From Discovery To Impact: New Approach Methodologies")
Human‑relevant models deliver greatest value with clear questions, rigorous execution, and confident interpretation — turning innovation into trusted evidence for development and regulatory decisions.
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![Nasal spray, allerfies, common cold-GettyImages-2147519597]( "Nasal Drug Delivery")
How integrated analytics, formulation, and manufacturing enable fast‑acting, noninvasive nasal therapies while helping teams align delivery needs, regulations, and performance goals.
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![Biological drug products]( "Blow/Fill/Seal Packaging Systems")
Weiler Engineering’s ASEP-TECH® Blow/Fill/Seal machines are ideal for processing temperature sensitive products such as biological and protein-based materials – providing a level of enhanced sterility assurance.
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![ulab thumb]( "Battelle uLAB")
This comprehensive suite of services encompasses the entire spectrum of user research, starting from the conceptualization of study designs to meticulous data analysis and comprehensive reporting.
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![inhaler-GettyImages-2233485493]( "Pulmonary Drug Delivery")
Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.
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![Getty Images-823447656-vector-viral-lab-AAV-cell-development]( "Global Experts In Nanotechnology And Drug Particle Engineering")
Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."
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![GettyImages-884796056-solubility-test-pill]( "Pharmaceutical Development")
Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.
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![scientist in lab microscope-GettyImages-1867575565]( "NanoImprove The Performance Of Your Biologic Formulation")
Unlock superior performance for peptides and proteins using nanotechnology. Achieve high drug loads for subcutaneous delivery and stable, aerodynamic dry powders for deep-lung inhalation.
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![analytical-timelines-GettyImages-2247278213]( "A Comprehensive Approach That's Exceptional By Design")
An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.
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![Blow Fill Seal Packaging]( "Blow-Fill-Seal Packaging Systems For Large Volume Nebulizers And Humidifiers")
Large volume humidifiers and nebulizers – typically in sizes from 250 – 1000mL – can be specifically designed to fit existing delivery devices. Custom designs to facilitate the control of humidification in oxygen delivery can be developed.
