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See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.

Through case studies on modified release, poor solubility, and pediatrics, discover how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.

Optimize drug delivery by leveraging advanced nanoparticle engineering to dramatically increase small-molecule oral drug loading and enable ultra-high-concentration subcutaneous formulations.

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Fran DeGrazio, Executive Editor - Drug Delivery Leader & Frankly Fran

Fran offers keen industry and technical insights exclusively on Drug Delivery Leader.

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  • Unpacking The FDA Draft Guidance On Container Closure Systems

    In this article, Fran DeGrazio reflects on the significance of the FDA Draft Guidance on Container Closure Systems, the first update since 1999. DeGrazio places the CCS draft guidance in the current context of science-based and risk-based product development for combination products and other injectable drug product delivery systems. She also addresses the integration of CCS guidance into the development organization’s QMS (Quality Management System).

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DRUG DISCOVERY CONTENT COLLECTIONS

Why Human Factors Are Critical To Drug Delivery Device Success

In today’s highly competitive biopharma market, successful therapies prioritize the patient experience. Increasingly, patients expect to receive advanced therapies at home or in decentralized care settings, which require delivery methods that are easy to use and comfortable.

This collection explores how drug delivery teams can incorporate patient-centricity across development, from early human factors strategies to modality selection, ensuring safe, effective therapies that translate to real-world care.

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