SOCIAL QUESTIONS|health|medical science|toxicology
- staidéar eachtarshuímh tocsaineolaíoch Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- staidéar eachtarshuímh Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- bridging study | bridging studies | toxicological bridging study | toxicological bridging studies | bridging analysis | bridging analyses
- en
- Sainmhíniú supplemental study performed in a new region (region where product registration is sought) to provide pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the population in the new region Tagairt "COM-EN, based on:European Medicines Agency. ICH Topic E 5 (R1); 'Ethnic Factors in the Acceptability of Foreign Clinical Data' (10.3.2023)"