Target product profile (TPP) in the US
A TPP can be prepared by a sponsor and then shared with the appropriate FDA review staff to facilitate communication regarding a particular drug development program. Submission of a TPP is voluntary. Purpose of a TPP is to provide a format for discussions between a sponsor and the FDA that can be used throughout the drug development process, from pre-investigational new drug application (pre-IND) or investigational new drug application (IND) phases of drug development through post marketing programs to pursue new indications or other substantial changes in labeling.
Target product profile (TPP) in the EU
The Target product profile is referred to as the Quality Target Product Profile (QTPP) in the EU. The quality target product profile forms the basis of design for the development of the product. Considerations for the quality target product profile could include:
- Intended use in clinical setting, route of administration, dosage form, delivery systems;
- Dosage strength(s);
- Container closure system
- Therapeutic moiety release or delivery and attributes affecting pharmacokinetic characteristics (e.g., dissolution,aerodynamic performance) appropriate to the drug product dosage form being developed;
Drug product quality criteria (e.g., sterility, purity, stability and drug release) appropriate for the intended marketed product.