Kiermeier, A.Jarrett, R.Verbyla, A.2007-02-202007-02-202004Pharmaceutical Statistics, 2004; 3(1):3-111539-16041539-1612http://hdl.handle.net/2440/214<jats:title>Abstract</jats:title><jats:p>The current approach to the estimation of shelf‐life and the determination of the label shelf‐life as detailed in the International Conference on Harmonisation guidelines to industry is presented. The shortcomings of the status quo are explained and a possible solution is offered, which gives rise to a new definition of shelf‐life. Several methods for calculating a label shelf‐life are presented and investigated using a simulation study. Recommendations to adopt the new definition and to increase sample sizes are made. Copyright © 2004 John Wiley &amp; Sons, Ltd.</jats:p>enConstraintQuantileStability analysisModified profile likelihoodJournal article002004023910.1002/pst.78Shelf-life0002202325000012-s2.0-1064427721157194Kiermeier, A. [0000-0001-6240-2919]Jarrett, R. [0000-0002-5574-5099]