Futility rules in bioequivalence trials with sequential designs

AAPS Journal

Volumn 16, Issue 1, 2014, Pages 79-82

  Fuglsang, Anders ^a  

^a Fuglsang Pharma   (Denmark)

Author keywords

Alpha; Bioequivalence; Futility rules; Power; Sequential design

Indexed keywords

ANALYTICAL ERROR; ARTICLE; BIOEQUIVALENCE; CANADA; COMPUTER PROGRAM; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; PERFORMANCE MEASUREMENT SYSTEM; POWER ANALYSIS; PRACTICE GUIDELINE; PUBLICATION; REFERENCE VALUE; RESEARCH ETHICS; SEQUENTIAL ANALYSIS; SIMULATION;

CLINICAL TRIALS AS TOPIC; HUMANS; MEDICAL FUTILITY; STATISTICS AS TOPIC; THERAPEUTIC EQUIVALENCY;

EID: 84893679345     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-013-9540-0     Document Type: Article

References (5)

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. Committee for Human Medicinal Products. Investigation of Bioequivalence. European Medicines Agency, 2010. Available via http://www.ema.europa.eu/ema/ pages/includes/document/open-document.jsp?webContentId=WC500070039
4. Steering Committee (International Conference of Harmonization). Statistical Principles for Clinical Trials. International Conference of Harmonization. 1998. Available via http://www.ich.org/fileadmin/Public-Web-Site/ ICH-Products/Guidelines/Efficacy/E9/Step4/E9-Guideline.pdf
5. Karalis V, Macheras P. An insight into the properties of a two-stage design in bioequivalence studies. Pharm Res. 2013;30:1824-35.