Target Product Profile Development and Indication Prioritization
We can help you write a Target Product Profile (TPP) and evaluate the regulatory and approval precedent.
We can help you identify which indications to prioritize and help to plan the development programme for an asset.
Gain Understanding
We can evaluate approval precedent.
A good target product profile defines the characteristics of your medicine product. This will include the targeted populations, your product's target indication, treatment durations and regimens, as well as safety and efficacy characteristics.
Increasingly, early-phase development may revolve around the use of basket studies to identify safety and activity in patients with potentially different conditions. This is often the case with targeted therapies in oncology.
Roadmap
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FAQs
What is the TPP in medicine development?
According to the World Health Organisation, a TPP is a planning tool that guides medicine development to ensure a drug or biologic meets the minimum desired characteristics for its intended use and target population.
Why is the target product profile important?
Providing a detailed analysis of the regulatory landscape and potential TPP can be helpful in prioritizing the indication for registration and establishing the development pathway, duration and cost.