Newsletter | March 25, 2024

03.25.24 -- Use-Related Risk Analysis For Combination Products


Use-Related Risk Analysis For Combination Products

One of the most integral components in the development of drug-device combination products is the use-related risk analysis (URRA) and its applicability to the overall human factors engineering process. Deficiencies in the URRA are a leading cause of delays with FDA submissions.


Preclinical Swine Model Of Large Volume Subcutaneous Injection Pressure Predictive And Translational To Clinical Human Model

The transition of intravenous in-clinic chronic disease therapies to large volume subcutaneous injections in alternate settings has created an evolving roster of new formulations and treatment options.

Your Approach To USP <382> For Your Drug Product Packaging

USP requirements for elastomeric components of container closure systems used for parenteral products are changing. Explore the implications for vial, syringe, and cartridge closure systems.

Alternative Coating Technologies To Silicone Oil For Prefillable Syringes

The challenges of silicone-oil lubrication and the growing trend for more viscous, protein-based drugs are now leading pharma and biotech companies to investigate alternative solutions.

Examining The Emergence Of Unit- And Bi-Dose Nasal Sprays

Experts discuss the advantages and opportunities of adopting unit- and bi-dose nasal delivery technology over oral and intravenous (IV) delivery.

Overcoming Delivery System Melt Processing Challenges

Discover how a biodegradable polymer platform that can be easily applied enables processing at a relatively low temperature, preserving the potency of temperature-sensitive APIs.


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