Phase II Clinical Development of New Drugs

• Κύριοι συγγραφείς: Ting, Naitee (Συγγραφέας), Chen, Ding-Geng (Συγγραφέας), Ho, Shuyen (Συγγραφέας), Cappelleri, Joseph C. (Συγγραφέας)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Singapore : Springer Singapore : Imprint: Springer, 2017.
• Σειρά: ICSA Book Series in Statistics,
• Θέματα: 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...

Πίνακας περιεχομένων:

• 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.