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Clinical Study Report, Bioequivalence, General Concepts and Overview

Clinical Study Report, Bioequivalence, General Concepts and Overview

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To assist sponsors in the development of a report that is complete, free from ambiguity, well organized, and easy to review
To assist sponsors in the development of a report that is complete, free from ambiguity, well organized, and easy to review

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Published by: Ahmad Abdullah Najjar on Jul 29, 2008
Copyright:Attribution Non-commercial

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06/23/2011

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Clinical Study Report:Bioequivalence, Generalconcepts and overview
Ariya Khunvichai, Ph.D.20 April 2007
 
Objective
To assist sponsors in the development of areport that iscomplete, free from ambiguity,well organized, and easy to review
a clear explanation of how the critical designfeatures of the study were chosen
analytical methods
full description of safety, all individual subjectdata (PK ,adverse events or laboratoryabnormalities, demographic information)
data listings (usually in Appendix)
 
General Information
Data should be presented in the report atdifferent levels-
Most important data (fig, tab) should be placed inthe text to illustrate important points; others shouldbe provided in section 14 or 16.
In any table, figure or data listing, detailedexplanations should be provided

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