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Comments on the draft guidance on “Adaptive design clinical trials for drugs and biologics” of the U.S. Food and Drug Administration
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Brannath, Werner, Burger, Hans Ulrich, Glimm, Ekkehard, Stallard, Nigel, Vandemeulebroecke, Marc and Wassmer, Gernot (2010) Comments on the draft guidance on “Adaptive design clinical trials for drugs and biologics” of the U.S. Food and Drug Administration. Journal of Biopharmaceutical Statistics, Vol.20 (No.6). pp. 1125-1131. doi:10.1080/10543406.2010.514453
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Official URL: http://dx.doi.org/10.1080/10543406.2010.514453
Abstract
The U.S. FDA has published a draft guidance on oAdaptive Design Clinical Trials for Drugs and Biologicso, which gives regulatory guidance on methodological issues in exploratory and confirmatory clinical trials planned with an adaptive design. This comment summarizes the discussion within the joint working group oAdaptive Designs and Multiple Testing Procedureso of the Austro-Swiss and German regions of the International Biometric Society held at the 90-day public comment period in spring 2010.
| Item Type: | Journal Article | ||||
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| Subjects: | Q Science > QA Mathematics R Medicine > R Medicine (General) R Medicine > RS Pharmacy and materia medica |
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| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Clinical trials -- Design, United States. Food and Drug Administration, Biologicals -- Testing, Drugs -- Testing, Drug development | ||||
| Journal or Publication Title: | Journal of Biopharmaceutical Statistics | ||||
| Publisher: | Taylor & Francis Inc. | ||||
| ISSN: | 1054-3406 | ||||
| Official Date: | 2010 | ||||
| Dates: |
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| Volume: | Vol.20 | ||||
| Number: | No.6 | ||||
| Number of Pages: | 7 | ||||
| Page Range: | pp. 1125-1131 | ||||
| DOI: | 10.1080/10543406.2010.514453 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published | ||||
| Access rights to Published version: | Restricted or Subscription Access | ||||
| Description: | Special Issue: Special theme for adaptive clinical trial design |
Data sourced from Thomson Reuters' Web of Knowledge
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