title: Calculation of tolerance limits and sample size determination for clinical trials with dichotomous outcomes.
abstract: This research provides an algorithm for calculating uniformly most accurate tolerance intervals in clinical trials with dichotomous outcomes. The link between confidence intervals for proportions and tolerance intervals for numbers of outcomes is established. Tolerance intervals and sample size estimates for clinical trials may be calculated using StatXact.
authors.affiliation: Food and Drug Administration, Rockville, MD 20850, USA. Boris.Zaslavsky@FDA.HHS.gov
authors.forename: Boris G
authors.initials: BG
authors.lastname: Zaslavsky
mesh_terms: D016010:Binomial Distribution; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D006801:Humans; D015233:Models, Statistical; D018401:Sample Size; D012984:Software; D016896:Treatment Outcome