title: Implementation of an adaptive group sequential design in a bioequivalence study.
abstract: The study design was a multi-center, multiple-dose, randomized, open-label, 2 x 2 crossover study in patients with advanced solid tumors. Each patient was randomized to receive the test formulation or the reference formulation of the drug. The primary objective of the study was to demonstrate the bioequivalence of the test formulation T relative to the reference formulation R. The primary pharmacokinetic endpoints were AUC and Cmax. Since there were different bioequivalence criteria, different endpoints, with different and highly variable coefficients of variation, an adaptive design with a stopping rule for early establishing the bioequivalence as well as early stopping for futility with a flexible information-based monitoring based on error spending approach was implemented to manage uncertainty in assumptions of variability and expected slow enrollment rates.
authors: GlaxoSmithKline, Philadelphia, PA, USA. nbandyop@prdus.jnj.com
authors: Nibedita
authors: N
authors: Bandyopadhyay
authors: Vladimir
authors: V
authors: Dragalin
mesh_terms: D000970:Antineoplastic Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019540:Area Under Curve; D018592:Cross-Over Studies; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D013810:Therapeutic Equivalency
chemical_list: D000970:Antineoplastic Agents