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Knowledge generation and risk reduction are goals of combination product testing. A risk-based, and standards-based, testing strategy creates not only a quality product, but ensures continuity between past and future data sets. This enables the long-term, safe and efficient delivery of drug products to patients. And time to market is improved by reducing product launch false starts.
Combination product testing is a thrust area for West Analytical Services, LLC. In line with this, Daniel L. Bantz (Technology Manager, Performance and Packaging) and Jennifer Riter (Senior Director) recently presented the webinar: Demystifying Performance Testing: Strategies to Qualify Combination Products.
This webinar focused on design verification studies for combination products. Key points discussed were: (a) evaluation of physical aspects of device component performance, (b) evaluation of physiochemical interactions with the drug product, (c) risk reduction, and (d) reliance upon established standards and regulatory requirements/guidances. When properly executed, highest quality and rapidly approved/marketed products are the result. On behalf of clients, West Analytical Services, LLC maintains the staff, expertise and facility to design and execute these studies. For more on how West can provide support, please contact us here.
What’s the best strategy to create a holistic syringe-based combination product performance testing program? Start with the fundamentals - FDA Guidance Documents, ISO and USP considerations.
There are many benefits associated with the use of combination products (e.g., SmartDose® and SelfDose® Drug Delivery Platforms). Since combination products are often patient centered, they are designed to be convenient, assist in maintaining a drug therapy from home, and help to enable better compliance. To ensure these benefits, developers must formulate and execute a proper design verification study to minimize impacts by unknown risks. <br />
Earlier this year, we held a free 3-day virtual workshop (4 hours per day) bringing together industry experts and thought leaders in a unique forum to address a series of challenges and practical strategies to de-risk their injectable combination product development and commercialization.
Commitment to the safest and most efficient delivery of drug products requires a detailed understanding of the constantly changing regulatory landscape. Recently West presented a webinar series discussing the current regulatory requirements for packaging/delivery components and systems, to support not only customers, but the industry as a whole. Each averaged more than 300 registrants – clearly showing the interest in these areas.
Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
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