Phase II Clinical Development of New Drugs

Shuyen Ho, Naitee Ting, Ding-Geng Chen, et al.

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Springer Singapore img Link Publisher

Naturwissenschaften, Medizin, Informatik, Technik / Wahrscheinlichkeitstheorie, Stochastik, Mathematische Statistik

Beschreibung

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.

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Schlagwörter

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