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Article

Usability in injectable drug delivery

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This article from the June issue of On Drug Delivery discusses an overview of some of the appications for injection devices and the issues that can affect their useage. Advanced injection devices such as autoinjectors and injector pens offer many benefits over conventional syringes, including ease of use, convenience and patient feedback, all of which can drive up compliance and improve clinical outcomes.

Advanced injection devices such as autoinjectors and injector pens offer many benefits over conventional syringes, including ease of use, convenience and patient feedback, all of which can drive up compliance and improve clinical outcomes.

However, a number of injection devices recently entering the market has suffered from product recalls, some of which can be attributed to use errors. This has prompted regulators to demand evidence that usability issues have been identified and addressed throughout the development process and a number of standards has been published recently to help device developers meet regulatory requirements and provide practical guidance. One of the primary standards is IEC62366, which sets out a process to explore and validate usability throughout development. The FDA now expects companies developing drug delivery devices to follow these standards or at least demonstrate an equivalent approach.
On Drug Delivery (PDF)

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