Analysis of Safety and Diagnostic Data     3



3.1 Introduction

3.2 Reference Intervals for Safety and Diagnostic Measures

3.3 Analysis of Shift Tables



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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