ICSA Book Series in Statistics

Biopharmaceutical Applied Statistics Symposium

Volume 3 Pharmaceutical Applications

Editors: Peace, Karl E., Chen, Ding-Geng, Menon, Sandeep (Eds.)

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  • Discusses updated design and analysis methods for biopharmaceutical clinical trialsIncludes chapters written by internationally respected authors from academia, government and industry who possess substantial hands-on experience designing and analyzing biopharmaceutical clinical trials
  • Provides illustrative examples of the design and analysis of biopharmaceutical clinical trials
  • Provides computer programs to facilitate the understanding and applications
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eBook 79,72 €
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  • ISBN 978-981-10-7820-0
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Hardcover 114,39 €
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  • ISBN 978-981-10-7819-4
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  • The final prices may differ from the prices shown due to specifics of VAT rules
About this book

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. 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 Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.

Table of contents (19 chapters)

Table of contents (19 chapters)
  • Targeted Learning of Optimal Individualized Treatment Rules Under Cost Constraints

    Toth, Boriska (et al.)

    Pages 1-22

  • Overview of Omics Biomarker Discovery and Design Considerations for Biomarker-Informed Clinical Trials

    Zhang, Weidong (et al.)

    Pages 23-52

  • Phase 3 Oncology Trials of Personalized Medicines with Adaptive Subpopulation Selection

    Chen, Cong (et al.)

    Pages 53-64

  • High-Dimensional Data in Genomics

    Amaratunga, Dhammika (et al.)

    Pages 65-73

  • Synergy or Additivity—The Importance of Defining the Primary Endpoint and the Approach to Its Statistical Analysis—A Case Study

    Rodda, Bruce E.

    Pages 75-89

Buy this book

eBook 79,72 €
price for Spain (gross)
  • ISBN 978-981-10-7820-0
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover 114,39 €
price for Spain (gross)
  • ISBN 978-981-10-7819-4
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
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Bibliographic Information

Bibliographic Information
Book Title
Biopharmaceutical Applied Statistics Symposium
Book Subtitle
Volume 3 Pharmaceutical Applications
Editors
  • Karl E. Peace
  • Ding-Geng Chen
  • Sandeep Menon
Series Title
ICSA Book Series in Statistics
Copyright
2018
Publisher
Springer Singapore
Copyright Holder
Springer Nature Singapore Pte Ltd.
eBook ISBN
978-981-10-7820-0
DOI
10.1007/978-981-10-7820-0
Hardcover ISBN
978-981-10-7819-4
Series ISSN
2199-0980
Edition Number
1
Number of Pages
XV, 426
Number of Illustrations
28 b/w illustrations, 46 illustrations in colour
Topics