One of the best ways to focus your technology and product development efforts is to use a Target Product Profile (TPP). In the second of this series of articles, we provide Part 2 of a TPP most relevant for drugs development. You can read about and download Part 1 here.
The TPP becomes a living reference document for the most current information on the indication for use, formulation and drug product characteristics, pre-clinical and clinical study requirements. A great benefit of using the TPP with a development team is that it provides the team with a vision and focus.
In Part 2 of the TPP for drug development, we highlight aspects of safety and dosing:
- Other efficacy measures: Additional efficacy measures that may be recorded, but are not required to obtain a successful positive clinical trial result.
- Expected safety outcome: The most important safety outcome measures. Ideally should be easy to interpret and sensitive to treatment differences.
- Dosage and administration: Route and site of administration, dosage volume and frequency, administering location and personnel.
- Contraindications: Known or expected contraindications
- How supplied: Expected form and packaging information
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Some forms of the TPP add economic and business questions, such as the unique selling proposition, key market drivers and potential development and commercial showstoppers. Download Part 2 of the Therapeutics TTP example and template.
Let us know what you think of our version of the TPP. We hope you find it useful.