Signal detection process is a set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, literature information or other data sources, there are new risks causally associated wit
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
In order for health authorities to monitor the safety of investigational drugs, sponsors of clinical trials are required to submit safety reports of certain adverse events that occur during their clinical trials.
Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.