Infusion Drug Delivery Resources

1. Combination Products: Market Trends And Regulatory Considerations 1/17/2024

   Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.

2. ​​Advancing Drug Delivery At Home: Auto IV Cannulation 6/15/2026

   Autonomous IV therapy extends care beyond clinics, using imaging, precision control, and adaptive intelligence to improve vein access and enable safe treatment in more settings.

3. Formulation Research Strategy For Discovery- Stage New Drug Candidates 1/24/2022

   Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.

4. Which Testing Does An Effective Certificate Of Analysis Include? 2/16/2022

   Discerning mandatory testing from supplemental testing for early-stage injectable or IV-infusion therapies streamlines CoA creation and promotes regulatory compliance.

5. 10 Ways To Align Your Medical Device With Human Factors Industry Best Practices 3/1/2024

   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.

6. Is Your Combination Product Drug-Led Or Device-Led? 11/30/2022

   The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”

7. Formulation Development From Preclinical To First-In-Human 1/24/2022

   A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.

8. T Cell Cryopreservation: Comparing Rigid Polymer Vials And Flexible Bags 7/20/2023

   This work evaluates the performance of rigid 50 mL COP vials as an alternative for cryogenic storage of T cells compared to existing flexible cryogenic bags. The results are timely given the emerging packaging requirements and larger batch sizes anticipated for allogeneic cell therapies under clinical development.

9. Hospital To Home: What It Means For Patients, Providers And Medical Devices 4/16/2025

   Healthcare is shifting homeward. With telehealth, connected devices, and user-friendly design, patients and caregivers now deliver hospital-level care safely and effectively outside clinical settings.

10. Developmental Testing Of IV Solutions 2/10/2022

    As IV-administered drugs proliferate, sponsors must understand the associated regulatory requirements, methodologies for useful/required information, and formulations suitable for administration.