INHALATION DRUG DELIVERY VIDEOS

Both a URRA (Use-Related Risk Analysis) and IFU (Instructions for Use) can help to mitigate the risk of user misuse of a combination product. In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers rationale for starting and conducting the URRA ahead of developing or finalizing IFU.

What if a formulation that removed the need for cold chain distribution was possible? Explore the formulation of vaccines and manufacturing considerations for dry powder inhaled vaccines.

Among the characteristics of a device design feature that helps identify it as an Essential Drug Delivery Output (EDDO) is “device dependent.” 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 differences between the concepts of device-dependent versus device-independent and illustrates why only the former is applicable to an EDDO.

What is management’s responsibility in the implementation of approaches to the new QMSR? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies underscores the criticality of management commitment to and engagement in the process.

INHALATION DRUG DELIVERY RESOURCES

INHALATION DRUG DELIVERY SOLUTIONS

  • Modern inhalation platforms, improved formulations, and greener propellants speed development and strengthen respiratory performance, with key factors guiding device choice and clinical readiness.

  • By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

  • 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.

  • Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.

  • Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."

  • Explore new approach methodologies, integrating in vitro and computational models to improve toxicology testing, and drug development, enhancing accuracy, efficiency, and human relevance.

  • 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.

  • Advanced particle engineering enhances the performance and life-cycle of therapeutics. Superior bioavailability, higher drug load, and improved stability are enabled for small and large molecules.

  • 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.

  • 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.