Active controlled studies in antibiotic drug development-Reference-Cited by-同舟云学术

Active controlled studies in antibiotic drug development

Published:2011-09 Issue:5 Volume:10 Page:454-460
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceut. Statist.

Author:

Dane Aaron¹

Affiliation:

1. AstraZeneca; Macclesfield; Cheshire; UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Reference27 articles.

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2. Non-inferiority trials: design concepts and issues-the encounters of academic consultants in statistics;D'Agostino;Statistics in Medicine,2003

3. Toward a consistent standard of evidence when evaluating the efficacy of an experimental treatment from a randomized active-controlled trial;Peterson;Statistics in Biopharmaceutical Research,2010

4. CHMP guideline on the choice of the non inferiority margin 2006 http://www.ema.europa.eu/docs/en\_GB/document\_library/Scientific\_guideline/2009/09/WC500003636.pdf

5. Reporting of noninferiority and equivalence randomized trials. An extension of the CONSORT statement;Piaggio;Journal of the American Medical Association,2006

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1. Progress in the Fight Against Multidrug-Resistant Bacteria 2005–2016: Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance;Clinical Infectious Diseases;2017-05-18

2. Beyond the GAIN Act: Some Thoughts on Expediting Antibacterial Development to Address the Problem of Antimicrobial Resistance;Pharmaceutical Medicine;2016-02-24

3. Number of Published Randomized Controlled Multi Center Trials Testing Pharmacological Interventions or Devices Is Increasing in Both Medical and Surgical Specialties;PLoS ONE;2014-07-14

4. Statistical considerations associated with a comprehensive regulatory framework to address the unmet need for new antibacterial therapies;Pharmaceutical Statistics;2014-06-15

5. Statistical Issues and Controversies in Active-Controlled, “Noninferiority” Trials;Statistics in Biopharmaceutical Research;2013-08