title: Ambiguous assignment of release data in stability studies.
abstract: Release data are often used improperly in stability studies by reproducing the same data and assigning it to each subset of a lot. The proper use of release data in stability studies is explored in this paper. The maximum likelihood solution is determined and compared with multiple imputation and one ad hoc procedure. Maximum likelihood is seen not to lead to a practical solution. One such procedure is found to compare favorably with multiple imputation.
authors: Flower Valley Consulting, Inc., Rockville, Maryland 20853, USA. wrf343@flowervalleyconsulting.com
authors: William R
authors: WR
authors: Fairweather
mesh_terms: D003198:Computer Simulation; D004345:Drug Industry; D004355:Drug Stability; D008962:Models, Theoretical; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000706:statistics & numerical data*
chemical_list: D004364:Pharmaceutical Preparations