A comparison of expiration dating period estimation methods.
Two methods of estimating expiration date have been compared. For a drug whose potency is expected to decrease with time, method 1 fits a linear regression line to the stability data, calculates a 95% lower confidence limit of the true degradation line, and estimates the expiration date by comparing the confidence limit with the lower specification limit. Method 2 calculates a 95% lower confidence limit b1 of the slope of the true degradation line, constructs a new line y" using b1 as its slope, and finally estimates the expiration date by comparing y" with the lower specification limit. In this work we show that in most practical situations, method 1 estimates greater expiration date than method 2.
Rahman
M A
MA
Division of Biometrics, Food and Drug Administration, Rockville, Maryland 20857.
D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards; D004348:Drug Labeling / Q000592:standards / Q000706:statistics & numerical data*; D004349:Drug Packaging / Q000592:standards / Q000706:statistics & numerical data; D004355:Drug Stability; D012044:Regression Analysis; D013997:Time Factors