Considerations in developing a target product profile for parenteral pharmaceutical products.

A target product profile (TPP) describes how a product will be utilized by the end user. A systematically developed TPP can ensure alignment of objectives across company departments, accelerate development timelines, minimize development risks, and eventually lead to an optimal product. A TPP is particularly important for parenteral products due to the need for administration devices, the variety of possible end users (nurses, patients, pharmacists, and physicians), and requirements specific to sterile products. This manuscript describes key components of a TPP from a formulation development perspective and provides guidance on practical issues common to parenteral products.