03441nam 22006135 450 991025427380332120200703132359.0981-10-4194-610.1007/978-981-10-4194-5(CKB)3850000000027470(DE-He213)978-981-10-4194-5(MiAaPQ)EBC4840975(PPN)200511076(EXLCZ)99385000000002747020170412d2017 u| 0engurnn|008mamaatxtrdacontentcrdamediacrrdacarrierPhase II Clinical Development of New Drugs /by Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri1st ed. 2017.Singapore :Springer Singapore :Imprint: Springer,2017.1 online resource (XVII, 241 p. 25 illus., 17 illus. in color.) ICSA Book Series in Statistics,2199-0980981-10-4192-X Includes bibliographical references at the end of each chapters.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.ICSA Book Series in Statistics,2199-0980StatisticsPharmaceutical technologyManagementStatistics for Life Sciences, Medicine, Health Scienceshttps://scigraph.springernature.com/ontologies/product-market-codes/S17030Pharmaceutical Sciences/Technologyhttps://scigraph.springernature.com/ontologies/product-market-codes/B21010Managementhttps://scigraph.springernature.com/ontologies/product-market-codes/515000Statistics.Pharmaceutical technology.Management.Statistics for Life Sciences, Medicine, Health Sciences.Pharmaceutical Sciences/Technology.Management.615.19Ting Naiteeauthttp://id.loc.gov/vocabulary/relators/aut941785Chen Ding-Gengauthttp://id.loc.gov/vocabulary/relators/autHo Shuyenauthttp://id.loc.gov/vocabulary/relators/autCappelleri Joseph Cauthttp://id.loc.gov/vocabulary/relators/autMiAaPQMiAaPQMiAaPQBOOK9910254273803321Phase II Clinical Development of New Drugs2124861UNINA