References
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Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry
I. INTRODUCTION AND SCOPE This document provides guidance to sponsors and applicants submitting i...
药物临床试验样本量估计指导原则（试行）
一、 概述 样本量估计，又称样本量确定，是药物临床试验设计的重要组成部分，也是确保研究具有合理性、准确性、可靠性、完整性和科学性的重要手段。通常，临床试验的样本要有充分的代表性，纳入的样本量必须...