Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.
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ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Opioid Reformulation Filed As A CMC Supplement In Less Than A Year
Some reformulation projects are more challenging than others. See how innovative processing equipment from Freund-Vector was leveraged to develop an efficient and effective solution.
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Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development
The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.
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A Solvent-Free, Fusion-Based ASD Manufacturing Process
Explore a solvent-free alternative for the production of amorphous solid dispersions (ASDs) that not only improves manufacturability but also reduces the carbon footprint of ASD manufacturing.
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How Devices, Instructions, And Packaging Work Together To Improve Safety
A medical device's user interface is the entire product system: the device, labeling, packaging, and IFU. These elements are crucial for risk mitigation and must be tested holistically.
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Characterizing The E&L Profile Of Stoppers For Drug Stability
The significance of E&L testing lies in its ability to identify potential risks associated with the use of containers and packaging materials in the pharmaceutical industry.
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5 Ways Pre-Filled Syringes Contribute To Better Patient Outcomes
In our series on pre-filled syringes, we explore five key ways this delivery format is enhancing patient outcomes, not just through the medicine it contains, but through the device design itself.
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Delivering On GLP-1 Demand: Combining Device And Supply Strategy
Meeting the demand for GLP-1 treatments requires robust and efficient delivery systems. Review how innovative solutions offer customization, streamlined manufacturing, and formulation compatibility.
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Mitigating Hidden Risks: Extractables And Leachables
Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.
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Formulation Development From Preclinical To First-In-Human
A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.
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Formulation Considerations For Pediatric Populations
By partnering with a CDMO with experience in pediatric formulation, pharmaceutical companies can increase acceptability of their drugs among pediatric patients.

