Pharmaceutical Statistics

MBSW 39, Muncie, Indiana, USA, May 16-18, 2016

  • Ray Liu
  • Yi Tsong
Conference proceedings MBSW 2016

Part of the Springer Proceedings in Mathematics & Statistics book series (PROMS, volume 218)

Table of contents

  1. Front Matter
    Pages i-xi
  2. Specification and Sampling Acceptance Tests

  3. Analytical Biosimilar and Process Validation

  4. Continuous Process

  5. Clinical Trial Design and Analysis

    1. Front Matter
      Pages 129-129
    2. Cyrus Mehta, Lingyun Liu, Pranab Ghosh, Ping Gao
      Pages 131-139
    3. Jian Zhu, Ina Jazić, Yi Liu
      Pages 141-155
    4. Miao Yang, Zhaowei Hua, Saran Vardhanabhuti
      Pages 157-165
  6. Biomarker-Driven Trial Design

  7. Application of Novel Data Modality

  8. Omics Data Analysis

    1. Front Matter
      Pages 315-315
    2. Wencan Zhang, Pingye Zhang, Feng Gao, Yonghong Zhu, Ray Liu
      Pages 327-337

About these proceedings


This book presents the proceedings of the 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW), held in Muncie, Indiana on May 16–18, 2016. It consists of selected peer- reviewed and revised papers on topics ranging from statistical applications in drug discovery and CMC to biomarkers, clinical trials, and statistical programming. All contributions feature original research, and together they cover the full spectrum of pharmaceutical R&D – with a special focus on emergent topics such as biosimilarity, bioequivalence, clinical trial design, and subgroup identification.

Founded in 1978, the MBSW has provided a forum for statisticians to share knowledge, research, and applications on key statistical topics in pharmaceutical R&D for almost forty years, with the 2016 conference theme being “The Power and 3 I’s of Statistics: Innovation, Impact and Integrity.” The papers gathered here will be of interest to all researchers whose work involves the quantitative aspects of pharmaceutical research and development, including pharmaceutical statisticians who want to keep up-to-date with the latest trends, as well as academic statistics researchers looking for areas of application.


pharmaceutical statistics clinical trial CMC biomarker subgroup analysis biosimilarity

Editors and affiliations

  • Ray Liu
    • 1
  • Yi Tsong
    • 2
  1. 1.Statistical Innovation and Consultation groupTakeda PharmaceuticalsCambridgeUSA
  2. 2.Division of Biometrics VI, CDERU.S. Food and Drug Administration Silver SpringUSA

Bibliographic information