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Chapter 26: Development Challenges and Opportunities for Drug/Device Combination Products

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Development of Biopharmaceutical Drug-Device Products

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 35))

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Abstract

Competent and timely development of drug delivery systems designed for self-administration requires a thoughtful organizational model, dedicated and centralized engineering project management, global design verification standards, and regulatory engagement. Advances in sensors, wireless communication technologies, mobile medical applications (MMA), and cloud-based data paradigms are empowering patients and healthcare providers. However, these opportunities are not without risk.

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Correspondence to Harold K. Yeager .

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© 2020 American Association of Pharmaceutical Scientists

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Yeager, H.K., Brokovich, M.R., Roe, M.J., Jansen, P.E. (2020). Chapter 26: Development Challenges and Opportunities for Drug/Device Combination Products. 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_26

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