Phase II Clinical Development of New Drugs

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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.
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.
First comprehensive book on the design and analysis of Phase II clinical trials Provides step-by-step illustrations for data analysis using statistical software R and SAS Serves as a reference book for clinical research statisticians, physicians, drug regulatory affairs experts, pharmacokineticists, project managers, and other health care professionals Includes supplementary material: sn.pub/extras

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Costs of Developing New Medicinal Products Investment in Developing a New Drug Phase III Clinical Trials Phase II Program Development Drug Development Process Execution of Phase II Drug Approval

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“It provides a hands-on approach to each subject, and the necessary statistical background is presented in the most non-mathematical way possible. … Throughout the book, the scope of each subject is well defined, and if the reader has the need for further support, useful references are helpfully recommended. … I would strongly recommend this book to anyone working in clinical development or with an interest in this field, regardless of their background.” (David Manteigas, ISCB News, iscb.info, Issue 65, June, 2018)
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