Phase IV study
A Phase IV study is a post-marketing surveillance study conducted after a drug, device, or intervention has received regulatory approval. Its primary purpose is to monitor long-term safety, detect rare adverse events, assess effectiveness in routine clinical practice, and explore new indications or populations not adequately represented in earlier trials. Phase IV evidence accumulates continuously throughout a product's commercial life.
Kilderegister
Siteringer kopiert ordrett fra metodens kilderegister. Ingen påstandsnivåverifisering er underforstått fra dem.
- International Conference on Harmonisation (ICH). (1994). ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports E3. ICH Secretariat. · URL
- Phase IV clinical trial. Wikipedia. · URL
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Relaterte metoder
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