Chapter 18: Design of Clinical In-Use Studies

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.