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. 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. 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.

  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. 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.

  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. 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.

  8. 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.

  9. 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.

  10. Computational Modeling Of Injection-Related Tissue Responses 6/15/2022

    Optimizing delivery along with the formulation is the key to successful clinical outcomes. Research is necessary to understand the relationship between body morphology, injection force, and needle length.