From Adaptive Design to Modern Protocol Design for Drug Development: Part I. Editorial and Summary of Adaptive Designs Session at the Third FDA/DIA Statistics Forum-Reference-Cited by-同舟云学术

From Adaptive Design to Modern Protocol Design for Drug Development: Part I. Editorial and Summary of Adaptive Designs Session at the Third FDA/DIA Statistics Forum

Published:2010-05 Issue:3 Volume:44 Page:325-331
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Wang Sue-Jane,Bretz Frank

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug guides,Pharmacology (nursing)

Link

http://link.springer.com/content/pdf/10.1177/009286151004400314.pdf

Reference13 articles.

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2. US Food and Drug Administration. Draft guidance for industry: adaptive design clinical trials for drugs and biologics. https://doi.org/www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf. Released on February 25, 2010, for public comment.

3. Ho TW, Mannix LK, Fan X, et al. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008;70:1304–1312.

4. Fan F, et al. A novel dose-finding trial in the development of a novel anti-migraine compound. EMEA/EFPIA 2nd Workshop: Adaptive Design in Confirmatory Trials. EMEA Headquarters, UK, 2009. https://doi.org/ww.efpia.eu/content/default.asp?PageID-559&DoclD-6919.

5. Gaydos B. Phase 2/3 adaptive design utilizing a Bayesian decision analytic approach to dose selection. EMEA/EFPIA 2nd Workshop: Adaptive Design in Confirmatory Trials. EMEA Headquarters, UK, 2009. https://doi.org/www.efpia.eu/content/default.asp?PageID-559&DoclD-6910.

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1. Idle thoughts of a ‘well-calibrated’ Bayesian in clinical drug development;Pharmaceutical Statistics;2016-01-21

2. A Commentary on the U.S. FDA Adaptive Design Draft Guidance and EMA Reflection Paper from a Regulatory Perspective and Regulatory Experiences;Practical Considerations for Adaptive Trial Design and Implementation;2014

3. A varying-stage adaptive phase II/III clinical trial design;Statistics in Medicine;2013-11-06

4. Similarities and Differences of Bayesian Designs and Adaptive Designs for Medical Devices: A Regulatory View;Statistics in Biopharmaceutical Research;2013-11

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