Two-stage designs for Phase 2 dose-finding trials
Author:
Affiliation:
1. Department of Biostatistics; University of North Carolina; Chapel Hill; NC 27599-7420; U.S.A.
2. Janssen R&D; 1125 Trenton-Harbourton Road; Titusville; NJ 08560; U.S.A.
Publisher
Wiley
Subject
Statistics and Probability,Epidemiology
Reference18 articles.
1. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use ICH harmonised tripartite guideline: E4 dose-response information to support drug registration. Current step 4 version, March 10, 1994 http://www.ich.org/LOB/media/MEDIA480.pdf
2. Adaptive designs for dose-finding based on efficacy-toxicity response;Dragalin;Journal of Statistical Planning and Inference,2006
3. An adaptive design for identifying the dose with the best efficacy/tolerability profile with application to a crossover dose finding study;Ivanova;Statistics in Medicine,2009
4. Implementation of a Bayesian adaptive design in proof of concept study;Smith;Pharmaceutical Statistics,2006
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