Estimation of the shelf-life of drugs with mixed effects models.
This paper proposes a normal mixed effects model for stability analysis. An EM algorithm is developed to compute the maximum likelihood estimates of regression coefficients of the fixed effects and random effects, and variance components. The likelihood ratio test is used for the preliminary testing of batch-to-batch variation. An example from a marketing stability study is given to illustrate the proposed procedure.
Chen
J J
JJ
Division of Biometry and Risk Assessment, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas 72079, USA.
Hwang
J S
JS
Tsong
Y
Y
D000465:Algorithms; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D016001:Confidence Intervals; D004355:Drug Stability; D004356:Drug Storage; D016018:Least-Squares Analysis; D008956:Models, Chemical; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012044:Regression Analysis; D013223:Statistics as Topic / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations