title: A two one-sided parametric tolerance interval test for control of delivered dose uniformity--part 2--effect of changing parameters.
abstract: This article examines the effects of changing parameters in the test which was proposed by the FDA at the October 2005 Advisory Committee meeting for confirming delivered dose uniformity in orally inhaled and nasal drug products. This article is an extension of the characterization study presented in an accompanying article (Part 1). The goal of this study is to understand how parameters of the test affect the test performance. The effects of changing test parameters such as target interval, maximum allowable proportion in the tail area, and sample size are examined. The results show that changing the maximum allowable tail area and/or the target interval have the largest impact on the test outcomes, i.e., probability of acceptance for a given batch mean and standard deviation. The presented information may provide potential users of the test with a set of tools for optimizing the test characteristics for a particular product.
authors: Discovery Analytics, GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
authors: Steve
authors: S
authors: Novick
authors: David
authors: D
authors: Christopher
authors: Monisha
authors: M
authors: Dey
authors: Svetlana
authors: S
authors: Lyapustina
authors: Michael
authors: M
authors: Golden
authors: Stefan
authors: S
authors: Leiner
authors: Bruce
authors: B
authors: Wyka
authors: Hans-Joachim
authors: HJ
authors: Delzeit
authors: Chris
authors: C
authors: Novak
authors: Gregory
authors: G
authors: Larner
mesh_terms: D000281:Administration, Intranasal; D000336:Aerosols; D000465:Algorithms; D002626:Chemistry, Pharmaceutical / Q000592:standards*; D016503:Drug Delivery Systems / Q000592:standards*; D009010:Monte Carlo Method; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000336:Aerosols