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Springer Proceedings in Mathematics & Statistics

Pharmaceutical Statistics

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

Editors: Liu, Ray, Tsong, Yi (Eds.)

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  • Presents research from the premier conference on statistical research and applications in pharmaceutical R&D
  • Offers original, peer-reviewed research
  • Addresses biosimilarity, bioequivalence, clinical trial design, and subgroup identification – emergent topics critical to current pharmaceutical R&D
  • Includes novel topics for statistical methodology research
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eBook $149.00
price for USA in USD (gross)
  • ISBN 978-3-319-67386-8
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $199.99
price for USA in USD
  • ISBN 978-3-319-67385-1
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

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.

About the authors

Ray Liu, PhD, is the Head of Statistical Innovation and Consultation at Takeda Pharmaceutical Company. Dr. Liu received his BS and MA degrees from the National Taiwan University, Taiwan and his PhD from Columbia University, USA. He currently oversees the development of novel methodologies and provides statistical consultation and project support to various functional areas in pharmaceutical R&D, including Discovery, CMC, Translational Research, and Outcome Research. Dr. Liu was the conference chair of the 38th and 39th Midwest Biopharmaceutical Statistics Workshop. He is the author of more than 30 statistical and scientific articles and book chapters, editor of the Springer book “Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics”, frequent conference speaker on Big Data and the member of the ASA, PSTC Stats working group, IQ consortium, and NCBLF.

  

Yi Tsong, PhD, is the Division Director of Biometrics at the Food and Drug Administration (FDA). He specializes in post-marketing risk assessment, drug manufacturing process control and quality assurance, active control non-inferiority/equivalence tests, adaptive design, bioequivalence and analytical biosimilarity, and QTc trials, and has published more than 90 articles in these areas. Dr. Tsong received his PhD in Statistics from the University of North Carolina at Chapel Hill, USA and did his post-doctoral training in cardiovascular prevention and biostatistics at Northwestern University Medical School, USA. He has served as the Treasurer, Board Director, and President of the International Chinese Statistical Association and currently serves as Associate Editor of Statistics in Medicine, the Journal of Biopharmaceutical Statistics,and Pharmaceutical Statistics.

Table of contents (23 chapters)

Table of contents (23 chapters)
  • Statistical Considerations in Setting Quality Specification Limits Using Quality Data

    Pages 3-12

    Tsong, Yi (et al.)

  • Counting Test and Parametric Two One-Sided Tolerance Interval Test for Content Uniformity Using Large Sample Sizes

    Pages 13-24

    Shen, Meiyu (et al.)

  • Sample Size Consideration for Equivalent Test of Tier-1 Quality Attributes for Analytical Biosimilarity Assessment

    Pages 27-43

    Wang, Tianhua (et al.)

  • A Probability Based Equivalence Test of NIR Versus HPLC Analytical Methods in a Continuous Manufacturing Process Validation Study

    Pages 45-54

    Manola, Areti (et al.)

  • A Further Look at the Current Equivalence Test for Analytical Similarity Assessment

    Pages 55-70

    Thomas, Neal (et al.)

Buy this book

eBook $149.00
price for USA in USD (gross)
  • ISBN 978-3-319-67386-8
  • Digitally watermarked, DRM-free
  • Included format: EPUB, PDF
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $199.99
price for USA in USD
  • ISBN 978-3-319-67385-1
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Pharmaceutical Statistics
Book Subtitle
MBSW 39, Muncie, Indiana, USA, May 16-18, 2016
Editors
  • Ray Liu
  • Yi Tsong
Series Title
Springer Proceedings in Mathematics & Statistics
Series Volume
218
Copyright
2019
Publisher
Springer International Publishing
Copyright Holder
Springer Nature Switzerland AG
eBook ISBN
978-3-319-67386-8
DOI
10.1007/978-3-319-67386-8
Hardcover ISBN
978-3-319-67385-1
Series ISSN
2194-1009
Edition Number
1
Number of Pages
XI, 337
Number of Illustrations
18 b/w illustrations, 102 illustrations in colour
Topics