The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in randomised controlled clinical trials.
Target Product Profile (TPP)
A TPP is a format for a summary of a drug development program described in terms of labeling concepts.
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.
Latest Glossary Definitions
Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. It should contain company questions, justifications or company positions, and appropriate summary information.
The effect that something is likely to have on the treatment of a particular group of people, or on the results of treating that group.
In relation to Policy 70, CCI shall mean any information contained in the clinical reports submitted to EMA by the applicant/MAH which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.
Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device.
A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clinical testing results and clinical evaluations, risk analysis and instructions for use/Labeling.
A systematic evaluation of the evidence on the outcomes of different drugs or other options for treating, preventing, or diagnosing a medical condition.
The conduct and/or synthesis of research comparing different benefits and harms of alternative interventions and strategies to prevent, diagnose, treat, and monitor health conditions in routine clinical practice (i.e. the real-world setting).
Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.
A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.