Statistical Issues in NDA 21239 Laura Lu, Ph.D FDA/CDER

4/19/01


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Table of Contents

Statistical Issues in NDA 21239 Laura Lu, Ph.D FDA/CDER

Objective

Trial GL 96-02 Objectives

Trial GL 96-02 Methods

Plasma Cortisol Concentrations

Plasma Cortisol Concentrations

Baseline Plasma Cortisol Concentrations Pre- and Post ACTH Stimulation

Plasma Cortisol Concentrations Pre- and Post ACTH Stimulation following DHEA

Plasma Cortisol Concentrations Before ACTH Stimulation on Day 0 and Day 28

Plasma Cortisol Concentrations After ACTH Stimulation on Day 0 and Day 28

Conclusions

Author: luho