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Phase II clinical development of new...

Ting, Naitee.

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Phase II clinical development of new drugs

Record Type:	Electronic resources : Monograph/item
Title/Author:	Phase II clinical development of new drugs/ by Naitee Ting ... [et al.].
other author:	Ting, Naitee.
Published:	Singapore :Springer Singapore : : 2017.,
Description:	xvii, 241 p. :ill. (some col.), digital ;24 cm.
[NT 15003449]:	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.
Contained By:	Springer eBooks
Subject:	Drugs - Testing. -
Online resource:	http://dx.doi.org/10.1007/978-981-10-4194-5
ISBN:	9789811041945

Phase II clinical development of new drugs
Phase II clinical development of new drugs[electronic resource] /by Naitee Ting ... [et al.]. - Singapore :Springer Singapore :2017. - xvii, 241 p. :ill. (some col.), digital ;24 cm. - ICSA book series in statistics,2199-0980. - ICSA book series in statistics..

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.

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.

ISBN: 9789811041945

Standard No.: 10.1007/978-981-10-4194-5doiSubjects--Topical Terms:

646233
Drugs
--Testing.

LC Class. No.: RM301.27

Dewey Class. No.: 615.580724

Phase II clinical development of new drugs
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245 0 0 $a Phase II clinical development of new drugs $h [electronic resource] / $c by Naitee Ting ... [et al.].
260 $a Singapore : $b Springer Singapore : $b Imprint: Springer, $c 2017.
300 $a xvii, 241 p. : $b ill. (some col.), digital ; $c 24 cm.
490 1 $a ICSA book series in statistics, $x 2199-0980
505 0 $a 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.
520 $a 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.
650 0 $a Drugs $x Testing. $3 646233
650 0 $a Drug development. $3 716904
650 1 4 $a Statistics. $3 517247
650 2 4 $a Statistics for Life Sciences, Medicine, Health Sciences. $3 891086
650 2 4 $a Pharmaceutical Sciences/Technology. $3 1001579
650 2 4 $a Management. $3 516664
700 1 $a Ting, Naitee. $3 2184875
710 2 $a SpringerLink (Online service) $3 836513
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830 0 $a ICSA book series in statistics. $3 2153476
856 4 0 $u http://dx.doi.org/10.1007/978-981-10-4194-5
950 $a Mathematics and Statistics (Springer-11649)