Comments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration
Author:
Affiliation:
1. a Medical University of Vienna , Austria
2. b Hoffmann-La Roche , Basel, Switzerland
3. c Novartis Pharma AG , Basel, Switzerland
4. d Warwick Medical School, University of Warwick , United Kingdom
5. e ADDPLAN GmbH , Cologne, Germany
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543406.2010.514453
Reference21 articles.
1. 21 CFR 314.126 . Adequate and well-controlled studies . Code of Federal Regulations , Title 21, Part 314.126 .
2. The advantages and disadvantages of adaptive designs for clinical trials
3. Flexible Two-Stage Designs: An Overview
4. Unbiased Estimation of Selected Treatment Means in Two-Stage Trials
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