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E9 - Statistical Principles for Clinical Trials

E9 - Statistical Principles for Clinical Trials

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Published by kappu_abb
ICH guidelines for conducting Clinical Trials
ICH guidelines for conducting Clinical Trials

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Categories:Types, Research, Science
Published by: kappu_abb on Jul 22, 2009
Copyright:Attribution Non-commercial

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05/24/2012

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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICALREQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMANUSE
ICH
 
H
 ARMONISED
T
RIPARTITE
G
UIDELINE
 S
TATISTICAL
P
RINCIPLES FOR
C
LINICAL
T
RIALS
 E9
Current
Step 4 
versiondated 5 February 1998
This Guideline has been developed by the appropriate ICH Expert Working Group andhas been subject to consultation by the regulatory parties, in accordance with the ICH  Process. At Step 4 of the Process the final draft is recommended for adoption to theregulatory bodies of the European Union, Japan and USA.
 
 E9Document History
FirstCodificationHistory DateNewCodification
November2005
 E9 Approval by the Steering Committee under
Step 2 
andrelease for public consultation.16January1997E9
Current
Step 4
version
E9 Approval by the Steering Committee under
Step 4 
andrecommendation for adoption to the three ICHregulatory bodies.5February1998E9
 
 
S
TATISTICAL
P
RINCIPLES FOR
C
LINICAL
T
RIALS
 
ICH Harmonised Tripartite Guideline
Having reached
Step 4 
of the ICH Process at the ICH Steering Committee meetingon 5 February 1998, this guideline is recommended foradoption to the three regulatory parties to ICH
TABLE
 
OF
 
CONTENTS
 
i

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