|
|
|
|
|
|
|
FIG. 1
Target product profilekey driver of the development plan. |
|
|
|
|
|
|
|
|
development investment is endorsed by the commercial organization on the basis that the TPP specifications are delivered at an agreed time and cost. If the TPP contract is to be changed, this must be renegotiated and an endorsement for the new contract secured to ensure that further investment is justified. |
|
|
|
|
|
|
|
|
The TPP is the pole star on which the development plan is focused. The TPP is valuable only if it is specific and quantitative. The TPP enables setting development checkpoints based on the minimum performance established in the TPP. The TPP should be defined by the project team because it is a multidisciplinary task. To frame the TPP, the team must define how the drug is intended to be used in the disease state. A good start for the project team is to attempt a pictorial (disease cartoon) depiction of the patient flow in a disease. This would highlight how the disease is detected and how the disease progresses both acutely and chronically. The types of |
|
|
|
|
|
