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.
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© 2020 American Association of Pharmaceutical Scientists
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Busby, D., Gallagher, K. (2020). Chapter 36: Considerations in the Development, Approval, and Commercialization of On-Body Delivery Devices Used in Combination with a Biologic. In: Jameel, F., Skoug, J., Nesbitt, R. (eds) Development of Biopharmaceutical Drug-Device Products. AAPS Advances in the Pharmaceutical Sciences Series, vol 35. Springer, Cham. https://doi.org/10.1007/978-3-030-31415-6_36
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DOI: https://doi.org/10.1007/978-3-030-31415-6_36
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Publisher Name: Springer, Cham
Print ISBN: 978-3-030-31414-9
Online ISBN: 978-3-030-31415-6
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