手法を比較

	アレニウス安定性試験	ファーマコビジランスにおけるPRR/ROR
分野	薬理学	薬理学
系統	Process / pipeline	Process / pipeline
提唱年	1889	2002
提唱者	Svante Arrhenius	Arne Melander and colleagues
種類	shelf-life prediction	safety signal detection
原典	Arrhenius, S. (1889). Über die Reaktionsgeschwindigkeit bei der Inversion von Rohrzucker durch Säuren. Zeitschrift für Physikalische Chemie, 4, 226-248.	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.
別名	Arrhenius model, shelf-life prediction, degradation kinetics	PRR, ROR, signal detection, adverse event monitoring
関連	3	3
概要	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.