Naitee Ting,
Ding-Geng Chen,
Shuyen Ho,
Joseph C. Cappelleri
e.a.
Springer Nature Singapore
e druk, 2018
9789811350740
Phase II Clinical Development of New Drugs
Specificaties
Paperback, blz.
|
Engels
Springer Nature Singapore |
2018
ISBN13: 9789811350740
Rubricering
Onderdeel van serie
ICSA Book Series in Statistics
Verwachte levertijd ongeveer 9 werkdagen
Gratis verzonden
Samenvatting
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 execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.
Specificaties
ISBN13:9789811350740
Taal:Engels
Bindwijze:paperback
Uitgever:Springer Nature Singapore
Inhoudsopgave
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.