ON-DEMAND WEBINARS

Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.

Explore the role of solid form services in helping meet accelerated timelines of the drug development lifecycle along with examples of robust workflows for fast and thorough solid form screens.

Process parameter and quality attribute relationships, including those for typical pre- and post-ASD unit operations, will be explored in the context of real-world examples.

Gain valuable insights into the jet milling process and Quality by Design approach for inhalation drug delivery and their potential applications in drug development.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

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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.

DELIVERED BY DEGRAZIO

  • Container Closure Systems For Biosimilars: Is There Regulatory Difference?

    In this article, Fran DeGrazio discusses the FDA’s draft guidance on container closure systems for biosimilar products. She highlights key takeaways and offers recommendations on implications that developers of biosimilar pharmaceutical products should consider in areas such as quality, testing, and documentation.

EDITORIAL COLLECTIONS KNOWLEDGE CENTER

Our Editorial Collections examine today’s biggest scientific, operational, and patient-centered drug delivery issues. These collections help companies navigate complex development decisions with in-depth analysis, real-world examples, and guidance from industry experts.

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