Patient Focus in Drug Delivery Under Real World Constraints
摘要
Pharmaceutical development teams are highly cross-functional and bring together a broad range of disciplines with a goal of developing a safe, effective, usable, and manufacturable combination product. During development, the needs of the different team members become apparent and can sometimes seem in conflict with the ideal patient-centric product presentation. In this chapter, we will explore these different needs and discuss how they might impact patient-centric decision making. In some cases, the usability engineer will need to consider their design options recognizing the constraints of the molecule itself and how it needs to be delivered. In other cases, the engineer will need to make trade-offs considering business constraints. Different examples will be discussed that highlight options for compromise and finding a middle ground. Ultimately, the earlier that developers can anticipate and understand product-specific constraints and trade-offs, the better equipped they are to make the best design decisions for their organization and for their patients.