On Power and Sample Size Calculation for QT Studies with Recording Replicates at Given Time Point

Author:

Chow Shein-Chung1,Cheng Bin2,Cosmatos Dennis3

Affiliation:

1. a Department of Biostatistics and Bioinformatics , Duke University School of Medicine , Durham, North Carolina, USA

2. b Department of Biostatistics , Columbia University , New York, New York, USA

3. c Biostatistics for Translational Development , Wyeth Research , Collegeville, Pennsylvania, USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference6 articles.

1. Sample Size Calculations in Clinical Research

2. ICH ( 2005 ). ICH E14 Guidance on the Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential for Non-Antiarrythmic Drugs . Geneva , Switzerland : International Conference on Harmonisation , May 2005 .

3. Evaluation of Drug-Induced QT Interval Prolongation

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