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. 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.

3. Navigating Regulatory Challenges In Oligonucleotide Therapeutics 12/12/2024

   Oligonucleotide therapies offer precise treatments for genetic disorders and chronic diseases. They face unique regulatory challenges but hold great promise, especially when combined with FDA engagement.

4. 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.

5. Wearable Injectors: An Alternative To Traditional Intravenous Administration 3/24/2022

   See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

6. Rational Design And Development Of Long-Acting Injectable Dosage Forms 1/26/2022

   The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.

7. Mitigating Hidden Risks: Extractables And Leachables 1/24/2022

   Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

8. Plan For Your Extractables And Leachables Studies To Meet Submission Timelines

   Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.

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. 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.