Sequential bioequivalence trial designs with increased power and controlled type i error rates

AAPS Journal

Volumn 15, Issue 3, 2013, Pages 659-661

  Fuglsang, Anders ^a  

^a NONE   (Denmark)

Author keywords

bioequivalence; dry powder inhalers; power; sequential designs; type I errors

Indexed keywords

ARTICLE; BIOEQUIVALENCE; DRY POWDER INHALER; ERROR; SAMPLE SIZE; STUDY DESIGN;

ALGORITHMS; CLINICAL TRIALS AS TOPIC; CROSS-OVER STUDIES; DRY POWDER INHALERS; HUMANS; RESEARCH DESIGN; SOFTWARE DESIGN; THERAPEUTIC EQUIVALENCY;

EID: 84879798855     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9475-5     Document Type: Article

References (3)

1. Potvin D, DiLiberti CE, Hauck WW, Parr AF, Schuirmann DJ, Smith RA. Sequential design approaches for bioequivalence studies with crossover designs. Pharm Stat. 2008;7:245-62.
2. Montague TH, Potvin D, Diliberti CE, Hauck WW, Parr AF, Schuirmann DJ. Additional results for 'Sequential design approaches for bioequivalence studies with crossover designs'. Pharm Stat. 2012;11:8-13. doi: 10.1002/pst.483.
3. Fuglsang A. Controlling type I errors for two-stage bioequivalence study designs. Clin Res Regul Aff. 2001;28:100-5.