© 2018

Biopharmaceutical Applied Statistics Symposium

Volume 3 Pharmaceutical Applications

  • Karl E. Peace
  • Ding-Geng Chen
  • Sandeep Menon

Part of the ICSA Book Series in Statistics book series (ICSABSS)

Table of contents

  1. Front Matter
    Pages i-xv
  2. Cong Chen, Wen Li, Xiaoyun (Nicole) Li, Robert A. Beckman
    Pages 53-64
  3. Dhammika Amaratunga, Javier Cabrera
    Pages 65-73
  4. Karl E. Peace, Uche Eseoghene Okoro, Kao-Tai Tsai
    Pages 241-260
  5. Shein-Chung Chow, Fuyu Song
    Pages 277-305
  6. Steven A. Gilbert, Ye Tan
    Pages 307-337
  7. Shankar S. Srinivasan, Vatsala Karwe, Li Hua Yue
    Pages 375-395
  8. Shankar S. Srinivasan, Li Hua Yue, Rick Soong, Mia He, Sibabrata Banerjee, Stanley Kotey
    Pages 397-420

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.


Optimal Individualized Treatment Rules Mixture Normal Distribution Personalized Medicine Phase III Oncology Genomics Trials Defining the Primary Endpoint Genomics Toxicity Probability Interval Alpha-recycling Carcinogenicity Studies Clinical Trials

Editors and affiliations

  • Karl E. Peace
    • 1
  • Ding-Geng Chen
    • 2
  • Sandeep Menon
    • 3
  1. 1.Jiann-Ping Hsu College of Public HealthGeorgia Southern UniversityStatesboroUSA
  2. 2.School of Social Work and Gillings School of Global Public HealthUniversity of North Carolina Chapel HillUSA
  3. 3.Boston UniversityCambridgeUSA

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
  • Series Abbreviated Title ICSA Book Series in Statistics
  • DOI
  • Copyright Information Springer Nature Singapore Pte Ltd. 2018
  • Publisher Name Springer, Singapore
  • eBook Packages Mathematics and Statistics Mathematics and Statistics (R0)
  • Hardcover ISBN 978-981-10-7819-4
  • Softcover ISBN 978-981-13-4006-2
  • eBook ISBN 978-981-10-7820-0
  • Series ISSN 2199-0980
  • Series E-ISSN 2199-0999
  • Edition Number 1
  • Number of Pages XV, 426
  • Number of Illustrations 28 b/w illustrations, 46 illustrations in colour
  • Topics Statistics for Life Sciences, Medicine, Health Sciences
  • Buy this book on publisher's site
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