Statistical Issues Including Design and Sample Size Calculation in Thorough QT/QTc Studies-Reference-Cited by-同舟云学术

Statistical Issues Including Design and Sample Size Calculation in Thorough QT/QTc Studies

Published:2008-05-08 Issue:3 Volume:18 Page:451-467
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Zhang Joanne¹,Machado Stella G.¹

Affiliation:

1. a Division of Biometrics VI, Office of Biostatistics/Office of Translational Sciences , Center for Drug Evaluation and Research, Food and Drug Administration , Silver Spring, Maryland, USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543400802020938

Reference24 articles.

1. Bioequivalence trials, intersection-union tests and equivalence confidence sets

2. New confidence bounds for QT studies

3. Design and Analysis for Drug Abuse Potential Studies: Issues and Strategies for Implementing a Crossover Design

4. A Confidence Interval for the Maximal Mean QT Interval Change Caused by Drug Effect

5. Discussion of papers of session 3: Bayes/empirical bayes

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