title: Evaluating the performance of the ICH guidelines for shelf life estimation.
abstract: The goal of shelf life estimation is to determine the storage time during which the entire product meets specification with acceptably high probability. The estimated shelf life should be "applicable to all future batches" (ICH Q1E, International Conference on Harmonization, 2003b). There is compelling evidence of issues with the International Conference on Harmonization (ICH) guidelines for shelf life estimation. Issues include fixed batch effects, poolability tests, and confidence intervals for the mean. Two conclusions from evaluating the ICH procedure are that batch effects should be random and that focus should be on a quantile. A procedure is needed that combines random batches with the ICH objective of estimating the minimum batch shelf life.
authors.affiliation: Novartis Oncology, Florham Park, NJ 07932, USA. mquinlan22@yahoo.com
authors.forename: Michelle
authors.initials: M
authors.lastname: Quinlan
authors.forename: Walter
authors.initials: W
authors.lastname: Stroup
authors.forename: James
authors.initials: J
authors.lastname: Schwenke
authors.forename: David
authors.initials: D
authors.lastname: Christopher
mesh_terms: D016001:Confidence Intervals; D004348:Drug Labeling; D004355:Drug Stability; D004356:Drug Storage / Q000592:standards / Q000706:statistics & numerical data*; D005062:European Union; D017408:Guidelines as Topic / Q000592:standards*; D007390:International Agencies; D007564:Japan; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000592:standards*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations