Infusion Drug Delivery Resources

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway 1/26/2022

    Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.

  6. 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.

  7. 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?”

  8. Small Is Powerful And Sustained

    Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

  9. 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.

  10. 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.