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| Multicentrično ispitivanje faze IV× | Analiza doza-odgovor× | |
|---|---|---|
| Oblast | Epidemiologija | Epidemiologija |
| Porodica | Process / pipeline | Process / pipeline |
| Godina nastanka≠ | 1980s–1990s (formalized with post-marketing requirements in modern drug regulation) | Conceptual roots 16th century; modern epidemiological application mid-20th century |
| Tvorac≠ | Regulatory agencies and pharmaceutical industry (ICH E2E, FDA, EMA post-marketing frameworks) | Paracelsus (conceptual foundation); formalized by John Snow and later Bradford Hill |
| Tip≠ | Observational or interventional post-marketing study | Quantitative analytical method |
| Temeljni izvor≠ | Strom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. John Wiley & Sons. ISBN: 978-0470029619 | Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641 |
| Drugi nazivi | multicenter post-marketing study, multicenter pharmacovigilance study, multi-site phase IV study, post-authorization safety study | exposure-response analysis, concentration-response modeling, dose-response modeling, DRA |
| Srodne≠ | 6 | 4 |
| Sažetak≠ | A multicenter Phase IV study is a post-marketing surveillance investigation conducted simultaneously at two or more clinical or research sites after a drug, device, or intervention has received regulatory approval. By pooling real-world data from diverse patient populations and geographic regions, it detects rare adverse events, evaluates long-term effectiveness, characterizes safety in subgroups, and fulfills regulatory post-authorization commitments that single-site studies cannot achieve. | Dose-response analysis quantifies the relationship between the magnitude of an exposure (the dose) and the probability or rate of an outcome (the response). It is a core analytical strategy in epidemiology and toxicology, providing evidence that increasing exposure systematically increases — or decreases — the risk of disease. A demonstrated dose-response gradient is one of Bradford Hill's classic criteria supporting causal inference. |
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