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Chapter 18: Design of Clinical In-Use Studies

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Book cover Development of Biopharmaceutical Drug-Device Products

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

Abstract

For most parenteral biologics, in-use manipulation of drug product during the aseptic dose solution preparation and administration process is inevitable. The in-use product handling procedures, and compatibility issues with administration components used in the clinical setting, can potentially impact protein stability. Therefore, it becomes imperative to define dose solution preparation, handling, and administration procedures that ensure the quality of the product solution administered to patients.

The general clinical in-use study design recommendations and case studies presented in this chapter highlight the commonly observed stability issues for parenteral intravenous protein products. This information can be used by pharmaceutical scientists as a practical guide to design and execute robust in-use studies through the development cycle of a drug product candidate.

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Authors and Affiliations

  1. Pharmaceutical Development, CMC Biologics, Oncology Early Development, AbbVie, Redwood City, CA, USA

    Supriya Gupta, Zhen Wu, Xiaofeng Lu, VivekKumar Garripelli & Hanmin Dong

  2. Formulation Development, New Biological Entities, AbbVie (United States), North Chicago, IL, USA

    Amr Alaarg, Zhen Wu, Xiaofeng Lu, VivekKumar Garripelli, Hanmin Dong & Bhargav Patel

  3. Formulation Development, New Biological Entities, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany

    Stephanie Sawilla & Rudolf Schroeder

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  1. Supriya Gupta
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Correspondence to Supriya Gupta .

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Editors and Affiliations

  1. Formulation Development New Biological Entities, AbbVie (United States), North Chicago, IL, USA

    Feroz Jameel

  2. Drug Product Development (Retired), AbbVie (United States), North Chicago, IL, USA

    John W. Skoug

  3. Combination Product Development, AbbVie, Inc., North Chicago, IL, USA

    Robert R. Nesbitt

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Gupta, S. et al. (2020). Chapter 18: Design of Clinical In-Use Studies. 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_18

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