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
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