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010   $a981-10-4194-6
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035   $a(DE-He213)978-981-10-4194-5
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035   $a(EXLCZ)993850000000027470
100   $a20170412d2017      u|         0
101 0 $aeng
135   $aurnn|008mamaa
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 10$aPhase II Clinical Development of New Drugs /$fby Naitee Ting, Ding-Geng Chen, Shuyen Ho, Joseph C. Cappelleri
205   $a1st ed. 2017.
210  1$aSingapore :$cSpringer Singapore :$cImprint: Springer,$d2017.
215   $a1 online resource (XVII, 241 p. 25 illus., 17 illus. in color.) 
225 1 $aICSA Book Series in Statistics,$x2199-0980
311   $a981-10-4192-X 
320   $aIncludes bibliographical references at the end of each chapters.
327   $aChapter 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.
330   $aThis book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.
410  0$aICSA Book Series in Statistics,$x2199-0980
606   $aStatistics
606   $aPharmaceutical technology
606   $aManagement
606   $aStatistics for Life Sciences, Medicine, Health Sciences$3https://scigraph.springernature.com/ontologies/product-market-codes/S17030
606   $aPharmaceutical Sciences/Technology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21010
606   $aManagement$3https://scigraph.springernature.com/ontologies/product-market-codes/515000
615  0$aStatistics.
615  0$aPharmaceutical technology.
615  0$aManagement.
615 14$aStatistics for Life Sciences, Medicine, Health Sciences.
615 24$aPharmaceutical Sciences/Technology.
615 24$aManagement.
676   $a615.19
700   $aTing$b Naitee$4aut$4http://id.loc.gov/vocabulary/relators/aut$0941785
702   $aChen$b Ding-Geng$4aut$4http://id.loc.gov/vocabulary/relators/aut
702   $aHo$b Shuyen$4aut$4http://id.loc.gov/vocabulary/relators/aut
702   $aCappelleri$b Joseph C$4aut$4http://id.loc.gov/vocabulary/relators/aut
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910254273803321
996   $aPhase II Clinical Development of New Drugs$92124861
997   $aUNINA