Phase II Clinical Development of New Drugs

• Main Authors: Ting, Naitee (Author), Chen, Ding-Geng (Author), Ho, Shuyen (Author), Cappelleri, Joseph C. (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Singapore : Springer Singapore : Imprint: Springer, 2017.
• Series: ICSA Book Series in Statistics,
• Subjects: Statistics.; Management.; Pharmaceutical technology.; Statistics for Life Sciences, Medicine, Health Sciences.; Pharmaceutical Sciences/Technology.

This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful exec...

Table of Contents:

• Chapter 1 Introduction
• Chapter 2 Concept of Alpha
• Chapter 3 Confirmation and Exploration
• Chapter 4 Design a Proof of Concept (PoC) Trial
• Chapter 5 Design of Dose-Ranging Trials
• Chapter 6 Combining PoC and Dose Ranging Trials
• Chapter 7 Risks of Inconclusiveness
• Chapter 8 Analysis of a PoC Study
• Chapter 9 Data Analysis for Dose-Ranging Trials with Continuous Outcome
• Chapter 10 Data Analysis of Dose-Ranging Trials for Binary Outcomes
• Chapter 11 Bayesian Methods
• Chapter 12 Overview of Phase III Clinical Trials.