Defining Your Target Product Profile: Therapeutics
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A target product profile (TPP) is a key strategic document that summarizes features of an intended commercial therapeutic product. A well-designed TPP provides a structure to ensure that a company embarks on a development program that is efficient and yet defines a listing of all relevant medical, technical and scientific information required to reach the desired commercial outcome.
This workbook will help you create a streamlined TPP for therapeutic products, either small molecule drugs or therapeutic proteins, used to treat or cure disease. The goal is to provide early-stage companies and new entrepreneurs with a scaled-down version of a TPP as well as experience in preparing such a technical document.
The exercise focuses on these key features of a therapeutic product:
- Indications and usage
- Dosage and administration
- Contraindications
- Adverse reactions
- Clinical pharmacology
- Non-clinical toxicology
- Clinical studies
Workbooks are comprised of two parts—the workbook guide, which contains instructions, examples and activities, and the workbook template, in which you can write your responses. You can personalize the workbook template by adding your company name and logo.
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| Workbook Guide Contains instructions, examples and activities. |
Workbook Template Write your responses and keep for your company’s records. |
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