title: Unit dose sampling and final product performance: an alternative approach.
abstract: This article documents a proposed plan for validation testing for the content uniformity for final blends and finished solid oral dosage forms (SODFs). The testing logic and statistical justification of the plan are presented. The plan provides good assurance that a passing lot will perforin well against the USP tablet content uniformity test. The operating characteristics of the test and the probability of needing to test for blend sampling bias are reported. A case study is presented.
authors.affiliation: Pharmaceutical Products Division, Abbott Laboratories, North Chicago, Illinois 60064-6325, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Geoffroy
authors.forename: D
authors.initials: D
authors.lastname: Leblond
authors.forename: R
authors.initials: R
authors.lastname: Poska
authors.forename: D
authors.initials: D
authors.lastname: Brinker
authors.forename: A
authors.initials: A
authors.lastname: Hsu
mesh_terms: D000465:Algorithms; D008509:Medication Systems / Q000706:statistics & numerical data*; D009010:Monte Carlo Method; D010602:Pharmacopoeias as Topic; D015203:Reproducibility of Results; D013607:Tablets; D014481:United States
chemical_list: D013607:Tablets