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Catalogue Information
Field name	Details
Dewey Class	519.5
Title	Phase II Clinical Development of New Drugs ([EBook]) / by Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri.
Author	Ting, Naitee
Added Personal Name	Chen, Ding-Geng author.
	Ho, Shuyen author.
	Cappelleri, Joseph C. author.
Other name(s)	SpringerLink (Online service)
Publication	Singapore : : Springer Singapore : : Imprint: Springer, , 2017.
Physical Details	XVII, 241 p. 25 illus., 17 illus. in color. : online resource.
Series	ICSA Book Series in Statistics 2199-0980
ISBN	9789811041945
Summary Note	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.:
Contents note	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.
System details note	Online access to this digital book is restricted to subscription institutions through IP address (only for SISSA internal users)
Internet Site	http://dx.doi.org/10.1007/978-981-10-4194-5
Links to Related Works	Subject References: Management . Pharmaceutical Sciences/Technology . Pharmaceutical technology . Statistics . Statistics for Life Sciences, Medicine, Health Sciences . Authors: Cappelleri, Joseph C. . Chen, Ding-Geng . Ho, Shuyen . Ting, Naitee . Corporate Authors: SpringerLink (Online service) . Series: ICSA Book Series in Statistics . Classification: 519.5 .

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Phase II Clinical Development of New Drugs

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