title: A modified large sample approach in the assessment of population bioequivalence.
abstract: The U.S. Food and Drug Administration (FDA) requires pharmaceutical companies to show bioequivalence between different formulations or generic companies to show bioequivalence between generic drugs and brand drugs before approval. In a recent FDA guidance on bioequivalence, new criteria were proposed for assessment of population and individual bioequivalence. In this article, computer simulation is used to compare a modified large sample (MLS) upper bound for the population bioequivalence ratio with the bootstrap upper bound recommended by the FDA. The comparison criteria are the ability to maintain the stated confidence level and the estimated power of tests based on these bounds.
authors: Quality Management and Technology Group, Dupont, Wilmington, Delaware 19898, USA.
authors: J
authors: J
authors: Quiroz
authors: N
authors: N
authors: Ting
authors: G C
authors: GC
authors: Wei
authors: R K
authors: RK
authors: Burdick
mesh_terms: D000465:Algorithms; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003198:Computer Simulation; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D011153:Population; D012107:Research Design; D018401:Sample Size; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration