Target Product Profile (TPP)
A Target Product Profile (TPP) is a technical document that outlines the desired characteristics and specifications of a new medical product.
- Contex:
- It can define a Medical Product intended use.
- It can outline the desired Patient Population and Clinical Need.
- It can specify the Technical Specifications of the product.
- It can identify Clinical Trial Endpoints.
- It can provide a regulatory strategy for obtaining approval from regulatory agencies.
- It can include a Marketing Strategy for launching the product.
- It can be referenced by a Clinical Development Plan (CDP).
- ...
- See: Clinical Trial Design.
References
2023
- chat
- A Target Product Profile (TPP) is a strategic document that outlines the desired characteristics and specifications of a new medical product or intervention, providing guidance on intended use, patient population, clinical need, technical specifications, clinical trial endpoints, regulatory strategy, and marketing strategy.
- Characteristics:
- It can define the intended use of the product.
- It can outline the desired patient population and clinical need.
- It can specify the technical specifications of the product.
- It can identify clinical trial endpoints.
- It can provide a regulatory strategy for obtaining approval from regulatory agencies.
- It can include a marketing strategy for launching the product in the market.
- Related terms: Medical product, clinical trial, regulatory approval, marketing strategy, patient population, technical specifications, clinical need, regulatory agencies, performance characteristics, diagnostic test.
2023
- chat
- A Target Product Profile (TPP) for an intervention is a document that outlines the desired characteristics and specifications of a new medical product or intervention, such as a drug, vaccine, medical device, or diagnostic test. The TPP is developed early in the development process and serves as a guide for product development, clinical trial design, and regulatory approval.
The TPP includes information on the product's intended use, patient population, and the clinical need it aims to address. It also outlines the product's proposed mechanism of action, safety and efficacy targets, dosage form, administration route, and any other relevant technical specifications and manufacturing requirements. Additionally, the TPP may include information on pricing, marketing, and distribution strategies.
The development of a TPP involves input from various stakeholders, including patients, clinicians, regulatory agencies, and other relevant experts. It serves as a tool to align development efforts around a clear set of goals and to ensure that the resulting product meets the needs of patients and healthcare providers.
- A Target Product Profile (TPP) for an intervention is a document that outlines the desired characteristics and specifications of a new medical product or intervention, such as a drug, vaccine, medical device, or diagnostic test. The TPP is developed early in the development process and serves as a guide for product development, clinical trial design, and regulatory approval.
2009
- (Tebbey & Rink, 2009) ⇒ Paul W. Tebbey, and Charles Rink. (2009). “Target Product Profile: A Renaissance for Its Definition and Use.” Journal of Medical Marketing 9, no. 4
- ABSTRACT: The Target Product Profile (TPP) is supposed to be the cornerstone of pharmaceutical product development. But how often is it utilized or updated, and how closely does it resemble the product that originally was envisaged? At a watershed moment for a drug development industry that recognizes the need for profound change in order to increase productivity, and with the US Food & Drug Administration promoting dialogue with pharmaceutical manufacturers via a ‘TPP’, it is an opportune time to revisit the important role that the TPP should play in the drug development process. In its traditional form, the TPP has proven to be insufficient for effective commercial evaluation of the clinical development strategy. But, rather than redefining the currently accepted form of the TPP, the authors propose a Strategic Evaluation Framework that encompasses the TPP, the vision for the brand and the prevailing needs of the marketplace. The Strategic Evaluation Framework augments the TPP with the additional information necessary for the assessment of a product's commercial potential. The Strategic Evaluation Framework constitutes the yardstick to track the developing product's actual clinical profile versus that necessary for commercial success and thereby serves as the guide for strategic clinical development decision making.