February 2005
Intermediate to advanced
430 pages
15h 6m
English
book
Analysis of Clinical Trials Using SAS
by Alex Dmitrienko, Geert Molenberghs, Christy Chuang-Stein, Walter W. Offen
Content preview from Analysis of Clinical Trials Using SAS
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Analysis of Safety and Diagnostic Data 3
3.2 Reference Intervals for Safety and Diagnostic Measures
This chapter describes methods for constructing reference intervals for safety and diagnostic measures in clinical trials. It discusses the computation of reference limits based on sample quantiles and tolerance limits, and it focuses on several issues that play an important role in drug development, such as methods for adjusting reference intervals for important prognostic factors. The second part of the chapter reviews statistical methods for the analysis of shift tables produced after reference intervals have been applied to safety and diagnostic data.
3.1 Introduction
Quantitative ...
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