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References
1.
Gaydos
B
Anderson
K
Berry
DA
Burnham
N
Chuang-Stein
C
Dudinak
J
Fardipour
P
Gallo
P
Givens
S
Krams
M
Lewis
R
Maca
J
Pinheiro
J
. Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development . Drug Info. J . 2009 ; 43 : 539 –565 .
2.
Gallo
P
Chuang-Stein
C
Dragalin
V
Gaydos
B
Krams
M
Pinheiro
J
. Executive summary of the PhRMA Working Group on Adaptive Designs in Clinical Drug Development . J Biopharm Stat . 2006 ; 16 : 275 –283 .
3.Committee for Medicinal Products for Human Use. CHMP reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. 2007 . www.emea.europa.eu/pdfs/human/ewp/245902enadopted.pdf. Accessed June 1, 2012 .
4.Food and Drug Administration . Guidance for Industry Adaptive Design Clinical Trials for Drugs and Biologics (draft). 2010 . http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf. Accessed June 1, 2012 .