Biopharmaceutical Applied Statistics Symposium Volume 3 Pharmaceutical Applications

Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies

Bibliographic Details
Other Authors: Peace, Karl E. (Editor), Chen, Ding-Geng (Editor), Menon, Sandeep (Editor)
Format: eBook
Language:English
Published: Singapore Springer Nature Singapore 2018, 2018
Edition:1st ed. 2018
Series:ICSA Book Series in Statistics
Subjects:
Online Access:
Collection: Springer eBooks 2005- - Collection details see MPG.ReNa
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245 0 0 |a Biopharmaceutical Applied Statistics Symposium  |h Elektronische Ressource  |b Volume 3 Pharmaceutical Applications  |c edited by Karl E. Peace, Ding-Geng Chen, Sandeep Menon 
250 |a 1st ed. 2018 
260 |a Singapore  |b Springer Nature Singapore  |c 2018, 2018 
300 |a XV, 426 p. 74 illus., 46 illus. in color  |b online resource 
505 0 |a Part I: Personalized Medicine -- 1 Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints -- 2 Uses of Mixture Normal Distribution in Genomics and Otherwise -- 3 Personalized Medicine – Design Considerations -- 4 Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials -- 5 High Dimensional Data in Genomics -- Part II:  Novel Applications -- 6 Synergy or Additivity - The Importance of Defining the Primary Endpoint -- 7 Full Bayesian Adaptive Dose Finding using Toxicity Probability Interval (TPI) -- 8 Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials -- 9 Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals -- 1 Clinical Trials in Orphan Drug Development -- 11 Mediation Modeling in Randomized Trials with Non-normal Outcome Variables -- 12 Statistical Considerations in Using Images in Clinical Trials -- 13 Interesting Applications over 30 Years of Consulting -- 14 Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials -- 15 Development and Evaluation of High Dimensional Prognostic Models -- 16 Design and Analysis of Biosimilar Studies 
653 |a Biostatistics 
653 |a Biometry 
700 1 |a Chen, Ding-Geng  |e [editor] 
700 1 |a Menon, Sandeep  |e [editor] 
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520 |a Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies 
520 |a The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development,  Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and OtherData Quality Issues in Clinical Trials,  
520 |a This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials.  The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications.   This book is the third of the 3-volume book series.