title: Using tolerance intervals for assessment of pharmaceutical quality.
abstract: In quality control of drug products, tolerance intervals are commonly used methods to assure a certain proportion of the products covered within a pre-specified acceptance interval. Depending on the nature of the quality attributes, the corresponding acceptance interval could be one-sided or two-sided. Thus, the tolerance intervals can also be one-sided or two-sided. To better utilize tolerance intervals for quality assurance, we reviewed the computation method and studied their statistical properties in terms of batch acceptance probability in this article. We also illustrate the application of one-sided and two-sided tolerance, as well as two one-sided tests through the examples of dose content uniformity test, delivered dose uniformity test, and dissolution test.
authors.affiliation: a Office of Biostatistics , /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring , Maryland , USA.
authors.forename: Xiaoyu
authors.initials: X
authors.lastname: Dong
authors.forename: Yi
authors.initials: Y
authors.lastname: Tsong
authors.forename: Meiyu
authors.initials: M
authors.lastname: Shen
authors.forename: Jinglin
authors.initials: J
authors.lastname: Zhong
mesh_terms: D001702:Biopharmaceutics / Q000592:standards / Q000706:statistics & numerical data*; D002626:Chemistry, Pharmaceutical; D003198:Computer Simulation; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D017408:Guidelines as Topic; D015233:Models, Statistical; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards*; D011786:Quality Control; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data*
chemical_list: D004364:Pharmaceutical Preparations
keywords: Acceptance criteria; Coverage hypothesis; One-sided tolerance interval; Two one-sided test; Two-sided tolerance interval