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Chapter 36: Considerations in the Development, Approval, and Commercialization of On-Body Delivery Devices Used in Combination with a Biologic

  • Donald BusbyEmail author
  • Kesley Gallagher
Chapter
  • 80 Downloads
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)

Abstract

Amgen has commercially marketed two on-body delivery devices for use in delivering a respective biologic. This chapter provides a high-level summary of the unique user needs for these devices as well as the development and commercialization process utilized to bring these products to market.

Keywords

On-body Delivery system ISO 11608 Requirements Standards Regulatory Human factors Risk Risk management Development partner Collaboration 

Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  1. 1.AmgenThousand OaksUSA

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