Infusion Drug Delivery Resources

1. Solubility With Lipid-Based Technologies For Oral & Injectable Formulations 11/7/2022

   Innovative approaches in developing formulations can help to improve a drug's safety and efficacy. Explore the decision for selecting the best-suited technology for formulating a complex molecule.

2. Contract Design And Development Vs. In-House: How To Find The Best Fit 3/21/2024

   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.

3. 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.

4. 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.

5. High-Throughput Platform Propels Gene Editing Therapy Research 3/1/2024

   Explore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.

6. 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.

7. 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.

8. 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.

9. 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.

10. ​​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.