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| Arheniusovo ispitivanje stabilnosti× | Farmakovigilancija PRR/ROR× | |
|---|---|---|
| Oblast | Farmakologija | Farmakologija |
| Porodica | Process / pipeline | Process / pipeline |
| Godina nastanka≠ | 1889 | 2002 |
| Tvorac≠ | Svante Arrhenius | Arne Melander and colleagues |
| Tip≠ | shelf-life prediction | safety signal detection |
| Temeljni izvor≠ | Arrhenius, S. (1889). Über die Reaktionsgeschwindigkeit bei der Inversion von Rohrzucker durch Säuren. Zeitschrift für Physikalische Chemie, 4, 226-248. link ↗ | 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 ↗ |
| Drugi nazivi≠ | Arrhenius model, shelf-life prediction, degradation kinetics | PRR, ROR, signal detection, adverse event monitoring |
| Srodne | 3 | 3 |
| Sažetak≠ | Arrhenius stability testing predicts pharmaceutical product shelf-life by conducting accelerated degradation studies at elevated temperatures and using the Arrhenius equation to extrapolate to storage conditions. Based on Svante Arrhenius's 1889 equation relating reaction rate to temperature, this method is regulatory standard for establishing expiration dates. | 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. |
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