Phase IV Clinical Trial
Post-marketing surveillance studies conducted after drug approval. Detect rare adverse events, evaluate long-term safety, explore new indications, and study drug use in special populations.
Exemplos
- REMS requirements
- Observational studies
- Registry-based studies
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Post-marketing surveillance studies conducted after drug approval. Detect rare adverse events, evaluate long-term safety, explore new indications, and study drug use in special populations.