Phase II Clinical Development of New Drugs
Design and Implementation| By: | Naitee Ting; Ding-Geng Chen; Shuyen Ho; Joseph C. Cappelleri |
| Publisher: | Springer Nature |
| Print ISBN: | 9789811041921 |
| eText ISBN: | 9789811041945 |
| Edition: | 0 |
| Copyright: | 2017 |
| Format: | Page Fidelity |
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Table of Contents
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.