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| Farmakovigilancija PRR/ROR× | Populaciono farmakodinamičko modelovanje× | |
|---|---|---|
| Oblast | Farmakologija | Farmakologija |
| Porodica | Process / pipeline | Process / pipeline |
| Godina nastanka≠ | 2002 | 1992 |
| Tvorac≠ | Arne Melander and colleagues | Lewis Sheiner and Stephen Roush |
| Tip≠ | safety signal detection | dose-response modeling |
| Temeljni izvor≠ | Szarfman, A., Tonning, J. M., Doraiswamy, P. M., & Osgood, D. J. (2002). Pharmacovigilance in the post-marketing setting: establishing causal links between drugs and adverse events. Drug Safety, 25(9), 619-631. link ↗ | Dahlström, B., & Nyberg, L. (1993). Population pharmacokinetics and pharmacodynamics. Clinical Pharmacokinetics, 24(1), 45-57. link ↗ |
| Drugi nazivi≠ | PRR, ROR, signal detection, adverse event monitoring | PopPD, population PD, hierarchical PD modeling |
| Srodne | 3 | 3 |
| Sažetak≠ | Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR) are statistical methods for detecting safety signals in spontaneous adverse event reporting databases. Developed and formalized by researchers in the early 2000s, these measures identify drug-adverse event associations that warrant further investigation. | Population pharmacodynamic (PopPD) modeling integrates pharmacokinetics with individual dose-response relationships across patient populations to characterize drug efficacy and tolerability. Pioneered by Lewis Sheiner and colleagues, PopPD accounts for inter-individual variability in drug effects and enables rational dose optimization and response prediction. |
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