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Testarea de Stabilitate Arrhenius×Factorul de similaritate f1/f2 pentru dizolvare×
DomeniuFarmacologieFarmacologie
FamilieProcess / pipelineProcess / pipeline
Anul apariției18891996
Autorul originalSvante ArrheniusJames Moore and Hector Flanner
Tipshelf-life predictionsimilarity testing
Sursa seminalăArrhenius, S. (1889). Über die Reaktionsgeschwindigkeit bei der Inversion von Rohrzucker durch Säuren. Zeitschrift für Physikalische Chemie, 4, 226-248. link ↗Moore, J. W., & Flanner, H. H. (1996). Mathematical comparison of dissolution profiles. Pharmaceutical Technology, 20(6), 64-74. link ↗
Denumiri alternativeArrhenius model, shelf-life prediction, degradation kineticsf1, f2, similarity factor
Înrudite33
RezumatArrhenius 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.The f1 and f2 factors are dimensionless statistical measures developed by Moore and Flanner to quantify the similarity between two dissolution profiles. Adopted by regulatory agencies (FDA, EMA) as the gold standard for comparing dissolution curves, these factors enable rapid assessment of whether formulation changes significantly impact drug release.
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ScholarGateCompară metode: Arrhenius Stability · Dissolution f1/f2 Similarity. Preluat la 2026-06-20 de pe https://scholargate.app/ro/compare