Device Design Space Update

Working Group:


ICH Q8 guidance examples are focused on how to establish design space for drug development, and need interpretation to be applied to drug delivery devices. The IPAC-RS Device Working Group has established a workstream to describe the steps in establishing the device design space. The Working Group is currently finalizing its proposal, which the Group plans to submit to the Board of Directors for endorsement later this year. Individuals interested in learning more about this initiative or becoming involved should contact Andy Dundon (andy.g.dundon@gsk.com).

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