Confirmatory efficacy testing for individual dose–placebo comparisons using serial gatekeeping procedure in dose‐finding trials with multiple comparison procedures

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Confirmatory efficacy testing for individual dose–placebo comparisons using serial gatekeeping procedure in dose‐finding trials with multiple comparison procedures–modeling

Published:2022-06-16 Issue:6 Volume:21 Page:1309-1323
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Yamaguchi Yusuke¹^ORCID,Sugitani Toshifumi²,Yoshida Satoshi³,Maruo Kazushi⁴^ORCID

Affiliation:

1. Biostatistics, Data Science Astellas Pharma Global Development, Inc. Northbrook Illinosis USA

2. Real World Evidence, Oncology Medical Bristol‐Myers Squibb Tokyo Japan

3. Data Science, Development Astellas Pharma Inc. Tokyo Japan

4. Department of Biostatistics, Faculty of Medicine University of Tsukuba Tsukuba Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2246

Reference45 articles.

1. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 1980-1999

2. Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012

3. Phase III trial failures: costly;Pretorius S;But Preventable Applied Clinical Trials,2016

4. Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014)

5. Design optimization for dose-finding trials: a review

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