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020 a| 9789811041921 (hardbound : alk. paper);

020 a| 981104192X (hardbound : alk. paper);

020 z| 9789811041945 (eBook);

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100 1 a| Ting, Naitee.;

245 10 a| Phase II clinical development of new drugsh| [electronic resource] /c| Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri.;

260 a| Singapore :b| Springer,c| [2017];

300 a| xvii, 241 pages :b| illustrations, portraits ;c| 25 cm;

490 1 a| ICSA book series in statistics,x| 2199-0980;

504 a| Includes bibliographical references.;

505 0 a| Concept of alpha -- Confirmation and exploration -- Design a proof of concept (PoC) trial -- Design of dose-ranging trials -- Combining PoC and dose ranging trials -- Risks of inconclusiveness -- Analysis of a PoC study -- Data analysis for dose-ranging trials with continuous outcome -- Data analysis of dose-ranging trials for binary outcomes -- Bayesian methods -- Overview of phase III clinical trials.;

506 a| Available only to authorized users.;

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.;

538 a| Mode of access: World Wide Web;

650 12 a| Drug Discoveryx| methods0| https://id.nlm.nih.gov/mesh/D055808Q000379;

650 22 a| Drug Evaluationx| methods0| https://id.nlm.nih.gov/mesh/D004341Q000379;

650 22 a| Clinical Trials, Phase II as Topicx| methods0| https://id.nlm.nih.gov/mesh/D017322Q000379;

650 22 a| Research Design0| https://id.nlm.nih.gov/mesh/D012107;

655 0 a| Electronic books.;

700 1 a| Chen, Ding-Geng.;

700 1 a| Ho, Shuyen.;

700 1 a| Cappelleri, Joseph C.;

830 0 a| ICSA book series in statistics,x| 2199-0980;

856 40 z| Full text available from Springer Nature - Springer Mathematics and Statistics eBooks 2017 English Internationalu| https://go.openathens.net/redirector/ecu.edu?url=https%3A%2F%2Flink.springer.com%2F10.1007%2F978-981-10-4194-5;

856 40 z| Full text available from Springer Booksu| https://go.openathens.net/redirector/ecu.edu?url=https%3A%2F%2Flink.springer.com%2F10.1007%2F978-981-10-4194-5;

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Phase II clinical development of new drugs / Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri.

Author/creator	Ting, Naitee
Other author	Chen, Ding-Geng.
Other author	Ho, Shuyen.
Other author	Cappelleri, Joseph C.
Format	Electronic
Publication Info	Singapore : Springer, [2017]
Description	xvii, 241 pages : illustrations, portraits ; 25 cm
Supplemental Content	Full text available from Springer Nature - Springer Mathematics and Statistics eBooks 2017 English International
Supplemental Content	Full text available from Springer Books
Subjects	Drug Discovery--methods. Drug Evaluation--methods. Clinical Trials, Phase II as Topic--methods. Research Design

Series	ICSA book series in statistics, 2199-0980 ICSA book series in statistics, 2199-0980
Contents	Concept of alpha -- Confirmation and exploration -- Design a proof of concept (PoC) trial -- Design of dose-ranging trials -- Combining PoC and dose ranging trials -- Risks of inconclusiveness -- Analysis of a PoC study -- Data analysis for dose-ranging trials with continuous outcome -- Data analysis of dose-ranging trials for binary outcomes -- Bayesian methods -- Overview of phase III clinical trials.
Abstract	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.
Bibliography note	Includes bibliographical references.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2017934053
ISBN	9789811041921 (hardbound : alk. paper)
ISBN	981104192X (hardbound : alk. paper)

Availability

Library	Location	Call Number	Status	Item Actions
	Electronic Resources	Online Content Full text available from Springer Nature - Springer Mathematics and Statistics eBooks 2017 English International Full text available from Springer Nature - Springer Mathematics and Statistics eBooks 2017 English International	✔ Available

Phase II clinical development of new drugs / Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri.

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